Multi-event July 2019 FDA Recall Sodium Chloride by Altaire Pharmaceuticals, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Altaire Pharmaceuticals, Inc. on July 2, 2019 for the product Sodium Chloride. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently completed.

Reported Recall Events

D-0373-2020 COMPLETED D-0381-2020 COMPLETED D-0397-2020 COMPLETED D-0431-2020 COMPLETED D-0354-2020 COMPLETED D-0352-2020 COMPLETED D-0357-2020 COMPLETED D-0355-2020 COMPLETED D-0362-2020 COMPLETED D-0416-2020 COMPLETED D-0353-2020 COMPLETED D-0361-2020 COMPLETED D-0356-2020 COMPLETED D-0379-2020 COMPLETED D-0464-2020 COMPLETED D-0483-2020 COMPLETED D-0430-2020 COMPLETED D-0411-2020 COMPLETED D-0455-2020 COMPLETED D-0436-2020 COMPLETED D-0474-2020 COMPLETED D-0422-2020 COMPLETED D-0451-2020 COMPLETED D-0425-2020 COMPLETED D-0358-2020 COMPLETED D-0447-2020 COMPLETED D-0448-2020 COMPLETED D-0468-2020 COMPLETED D-0438-2020 COMPLETED D-0359-2020 COMPLETED D-0389-2020 COMPLETED D-0407-2020 COMPLETED D-0429-2020 COMPLETED D-0375-2020 COMPLETED D-0423-2020 COMPLETED D-0391-2020 COMPLETED D-0461-2020 COMPLETED D-0454-2020 COMPLETED D-0432-2020 COMPLETED D-0374-2020 COMPLETED D-0446-2020 COMPLETED D-0413-2020 COMPLETED D-0426-2020 COMPLETED D-0417-2020 COMPLETED D-0466-2020 COMPLETED D-0487-2020 COMPLETED D-0419-2020 COMPLETED D-0395-2020 COMPLETED D-0486-2020 COMPLETED D-0366-2020 COMPLETED D-0396-2020 COMPLETED D-0440-2020 COMPLETED D-0376-2020 COMPLETED D-0434-2020 COMPLETED D-0365-2020 COMPLETED D-0456-2020 COMPLETED D-0442-2020 COMPLETED D-0443-2020 COMPLETED D-0489-2020 COMPLETED D-0427-2020 COMPLETED D-0467-2020 COMPLETED D-0415-2020 COMPLETED D-0387-2020 COMPLETED D-0435-2020 COMPLETED D-0463-2020 COMPLETED D-0420-2020 COMPLETED D-0450-2020 COMPLETED D-0472-2020 COMPLETED D-0459-2020 COMPLETED D-0401-2020 COMPLETED D-0405-2020 COMPLETED D-0392-2020 COMPLETED D-0404-2020 COMPLETED D-0385-2020 COMPLETED D-0380-2020 COMPLETED D-0478-2020 COMPLETED D-0370-2020 COMPLETED D-0421-2020 COMPLETED D-0414-2020 COMPLETED D-0441-2020 COMPLETED D-0403-2020 COMPLETED D-0418-2020 COMPLETED D-0367-2020 COMPLETED D-0363-2020 COMPLETED D-0437-2020 COMPLETED D-0398-2020 COMPLETED D-0424-2020 COMPLETED D-0479-2020 COMPLETED D-0453-2020 COMPLETED D-0382-2020 COMPLETED D-0412-2020 COMPLETED D-0371-2020 COMPLETED D-0462-2020 COMPLETED D-0364-2020 COMPLETED D-0457-2020 COMPLETED D-0445-2020 COMPLETED D-0394-2020 COMPLETED D-0384-2020 COMPLETED D-0471-2020 COMPLETED D-0452-2020 COMPLETED D-0439-2020 COMPLETED D-0465-2020 COMPLETED D-0406-2020 COMPLETED D-0393-2020 COMPLETED D-0378-2020 COMPLETED D-0410-2020 COMPLETED D-0458-2020 COMPLETED D-0473-2020 COMPLETED D-0433-2020 COMPLETED D-0482-2020 COMPLETED D-0481-2020 COMPLETED D-0409-2020 COMPLETED D-0386-2020 COMPLETED D-0444-2020 COMPLETED D-0449-2020 COMPLETED D-0480-2020 COMPLETED D-0470-2020 COMPLETED D-0475-2020 COMPLETED D-0390-2020 COMPLETED D-0369-2020 COMPLETED D-0368-2020 COMPLETED D-0469-2020 COMPLETED D-0360-2020 COMPLETED D-0372-2020 COMPLETED D-0477-2020 COMPLETED D-0490-2020 COMPLETED D-0485-2020 COMPLETED D-0388-2020 COMPLETED D-0476-2020 COMPLETED D-0428-2020 COMPLETED D-0383-2020 COMPLETED D-0402-2020 COMPLETED D-0399-2020 COMPLETED D-0377-2020 COMPLETED

Recall Number: D-0373-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
152,369 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : SEI 5/21 SGC 7/21 QGB 07/19 QID 09/19 RJC 10/20 RCJ 03/20 RCB 03/20 TCJ 03/22

Recall Number: D-0381-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
101712 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Dry Eye Relief Lubricant Eye Drops, 1 FL OZ (30 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 02895 Made in the USA

Batch or Lot Expiration Information

Lot# : 17277 09/19 18006 01/20 18098 04/21 18006 1/20 19057 02/22

Recall Number: D-0397-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15

Batch or Lot Expiration Information

Lot# 16260 9/19 17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22

Recall Number: D-0431-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
48,973 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-147-56

Batch or Lot Expiration Information

Lot# RGK 7/19 SDA 4/20 SFH 6/20 TAN 1/21

Recall Number: D-0354-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
87922 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35

Batch or Lot Expiration Information

Lot# : SEE, SEG, Exp 5/20; SIE, Exp 9/20; SKD, Exp 11/20

Recall Number: D-0352-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
1737549 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35

Batch or Lot Expiration Information

Lot# : RGC, Exp 7/19; RHB, RHC, Exp 8/19; RID, RIC, RIG, Exp 9/19; RKH, RKI, RKJ, RKK, RKL, Exp 11/19; RLM, Exp 12/19; SAI, Exp 1/20; SBG, SBH, Exp 2/20; SCF, Exp 3/20, SEA, Exp 5/20; SFA, SFB, Exp 6/20; SHA, Exp 8/20; SIB, Exp 9/20; SJC, Exp 10/20; TAB, TAF, Exp 1/21; TBP, TBQ, Exp 2/21; TCV, TCW, Exp 3/21

Recall Number: D-0357-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
41148 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35

Batch or Lot Expiration Information

Lot# : RJD, Exp 10/19; SHG, Exp 8/20

Recall Number: D-0355-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
261,528 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35

Batch or Lot Expiration Information

Lot# : RGD, Exp 7/19; RHL, Exp 8/19; RHB, Exp 9/19; RJF, Exp 10/19; RJG, Exp 10/19; SAJ, Exp 1/20; SAK, Exp 1/20; SAL, Exp 1/20; SAM, Exp 1/20; SBK, Exp 2/20; SEH, Exp 5/20; TCD, Exp 1/21

Recall Number: D-0362-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
43008 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road Deerfield IL 60015 NDC 0363-0193-13

Batch or Lot Expiration Information

Lot# : 19105, Exp 04/22; 19050, Exp 02/22

Affected Packages Involved in this Recall

0363-0193-13 Sodium Chloride

Recall Number: D-0416-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
46345 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Manufactured by: Altaire Pharmaceuticals Inc. Aquebogue, NY 11931, NDC 59390-184-50

Batch or Lot Expiration Information

Lot# SAP 1/20 3/16/2018 SFI 6/20 8/16/2018 SLA 12/20 1/4/2019 TBM 2/21

Affected Packages Involved in this Recall

59390-184-50 Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent

Recall Number: D-0353-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
121572 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35

Batch or Lot Expiration Information

Lot# : SAC, Exp 1/20; SLK, Exp 12/20

Recall Number: D-0361-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
30240 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net Wt. 0.125 oz (3.5 g), Distributed by Walgreen Co. 200 Wilmot Road Deerfield, IL 60015, NDC 0363-7500-50

Batch or Lot Expiration Information

Lot# : TCI , Exp 03/21

Affected Packages Involved in this Recall

0363-7500-50 Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye

Recall Number: D-0356-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
651528 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35

Batch or Lot Expiration Information

Lot# : RGA 7/19 7/31/2017; RGE 7/19 8/11/2017; RGG7/19 8/11/2017; RGH 7/19 8/17/2017; RHM 8/19 9/14/2017; RJB 10/19 10/23/2017; RJA 10/19 10/23/2017; SCA 3/20 3/22/2018; SIC 9/20 10/9/2018; TAP 1/21 2/26/2019; TDE 4/21 5/30/2019

Recall Number: D-0379-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
114,504 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39945 3

Batch or Lot Expiration Information

Lot# : RGF 07/19 RHN 08/19 RIH 09/19 RJP 10/19 RKN 11/19 SDC 04/20 SFC 06/20 SFJ 06/20 SGI 07/20 SKF 11/20 TAE 01/21

Recall Number: D-0464-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
84216 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15

Batch or Lot Expiration Information

Lot# 17375 12/19 17376 12/19 18190 7/20 18191 8/20

Recall Number: D-0483-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
31070 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15

Batch or Lot Expiration Information

Lot# : 18095, Exp 4/20

Recall Number: D-0430-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
24 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52

Batch or Lot Expiration Information

Lot# 19123 4/21

Recall Number: D-0411-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
464,424 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 18229 9/21 18031 1/21 17131 5/20 17059 3/20 17008 1/20 19056 03/22

Recall Number: D-0455-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
23974 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-192-05

Batch or Lot Expiration Information

Lot# 17041 2/20 17186 6/20 18068 3/21

Affected Packages Involved in this Recall

59390-192-05 Homatropine Hydrobromide Ophthalmic

Recall Number: D-0436-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
102,939 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05

Batch or Lot Expiration Information

Lot# 17244 8/19 18057 3/20 518307 12/20

Affected Packages Involved in this Recall

59390-140-05 Ofloxacin Ophthalmic

Recall Number: D-0474-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
195,864 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20

Batch or Lot Expiration Information

Lot# RKM 11/19 SGA 7/20 SIF 9/20 SKE 11/20

Recall Number: D-0422-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
532,961 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-205-05

Batch or Lot Expiration Information

Lot# 17099 4/20 6/1/2017 17254 8/20 9/14/2017 17255 8/20 9/15/2017 17361 12/20 12/26/2017 17362 12/20 4/4/2018 18088 4/21 4/30/2018 18089 4/21 5/1/2018 18138 6/21 6/25/2018 18146 6/21 6/29/2018 18156 6/21 8/6/2018 18212 8/21 10/2/2018 18276 11/21 12/26/2018 19082 3/22 5/1/2019 19098 4/22 5/21/2019 16282 10/19 11/11/2016 16283 10/19

Affected Packages Involved in this Recall

59390-205-05 Fluorescein Sodium And Proparacaine Hydrochloride

Recall Number: D-0451-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
29326 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30

Batch or Lot Expiration Information

Lot# 17208 7/21 17209 7/21 19001 1/23

Recall Number: D-0425-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
809,600 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35

Batch or Lot Expiration Information

Lot# 17087 3/20 17088 3/20 17109 4/20 17110 4/20 17306 10/20 17307 10/20 17318 10/20 17323 10/20 18014 1/21 18045 2/21 18059 3/21 18063 3/21 18117 5/21 18134 5/21 18228 9/21 18261 10/21 19119 4/22 16207 8/19 16233 8/19 16250 9/19 16268 10/19 16301 11/19

Recall Number: D-0358-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
195,864 unts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427

Batch or Lot Expiration Information

Lot# : RJH, Exp 10/19; SCC, Exp 3/21; SGA, Exp 7/21; SGH, Exp 7/21; SHH, Exp 8/21; SLL, Exp 12/21; TAC, Exp 1/22

Recall Number: D-0447-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
55,134 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01

Batch or Lot Expiration Information

Lot# 18026 1/21 18100 4/21 19052 2/22 19130 5/22

Recall Number: D-0448-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
296,314 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59

Batch or Lot Expiration Information

Lot# 16268 10/19 11/07/2016 16301 11/19 12/09/2016 17088 3/20 4/28/2017 17109 4/20 6/14/2017 17318 10/20 11/10/2017 17323 10/20 1/12/2018 18014 1/21 2/21/2018 18045 2/21 3/16/2018 18059 3/21 5/25/2018 18063 3/21 18117 5/21 18134 5/2

Recall Number: D-0468-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
TRP/ TARGET up & up intensive relief lubricating eye drop, 10 mL

Batch or Lot Expiration Information

Lot# 17290 9/19 18052 2/20

Recall Number: D-0438-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
47 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-146-52

Batch or Lot Expiration Information

Lot# 18099 4/20

Recall Number: D-0359-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
35,896 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL), Distributed by: Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, Item #801483

Batch or Lot Expiration Information

Lot# : 19095, Exp 04/21

Recall Number: D-0389-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
77,760 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : QHI 08/19 QJG 10/19 RBA 02/20 RCF 03/20 RCM 03/20 RDJ 04/20 RFA 06/20 RHI 08/20 RJI 10/20 RKG 11/20 SBF 2/21 SDD 04/21

Recall Number: D-0407-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
66,159 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 17291 9/19 17385 12/19 18118 5/20 18266 10/20

Recall Number: D-0429-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
13,407 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10

Batch or Lot Expiration Information

Lot# 17367 12/19 18102 4/20 18174 7/20

Recall Number: D-0375-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
100,680 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Item #247887

Batch or Lot Expiration Information

Lot# : 17222 07/19 17386 12/19 19018 01/21 18016 01/20 18181 07/20 18104 04/20 19018 1/21

Recall Number: D-0423-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
48,542 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13

Batch or Lot Expiration Information

Lot# 17241 8/20 8/24/2017 17322 10/20 12/21/2017 18169 7/20 7/30/2018 19052 2/22

Recall Number: D-0391-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
48,168 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5% Glycerin 1% Polysorbate 80 0.5%), Advanced Relief, 30 Sterile Single-Use Containers 0.02 fl. oz. (0.6 mL) each, Item #563442, NDC 50428 30295 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : RJM 10/19 RIA 09/19 SAN 01/20 SFF 06/20

Recall Number: D-0461-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
49527 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05

Batch or Lot Expiration Information

Lot# 17225 07/19 17247 08/19 18038 02/20 18162 06/20 19014 01/21

Affected Packages Involved in this Recall

59390-149-02 Diclofenac
59390-149-05 Diclofenac

Recall Number: D-0454-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
50,304 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 19087 03/21 18122 5/20 17289 9/19

Recall Number: D-0432-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
13,375 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-56

Batch or Lot Expiration Information

Lot# RGI 7/19 SDB 4/20 TAA 1/21

Recall Number: D-0374-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
365,832 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 17196 08/19 17192 09/19 17355 11/19 18024 01/20 18036 02/20 18237 09/20 18293 12/20 18105 04/20 18179 07/20 19040 2/21

Recall Number: D-0446-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
105609 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05

Batch or Lot Expiration Information

Lot# 17232 8/19 17334 11/19 18249 10/20 19125 4/21

Recall Number: D-0413-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
24,024 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# QHE 08/19 QJD 10/19

Recall Number: D-0426-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
202266 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13

Batch or Lot Expiration Information

Lot# 17112 4/20 17303 10/20 18032 2/21 18072 3/21 18193 8/20 18235 9/21 18285 11/21 19004 1/22 19102 4/22 16260 9/19

Affected Packages Involved in this Recall

59390-182-13 Goniotaire

Recall Number: D-0417-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
22494 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13

Batch or Lot Expiration Information

Lot# 18008 1/20 8/13/2018 19050 2/22 3/18/2019 19105 4/22

Affected Packages Involved in this Recall

59390-183-13 Altachlore Sodium Chloride Hypertonicity

Recall Number: D-0466-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
61830 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 68770-130-15

Batch or Lot Expiration Information

Lot# 17282 9/19 18121 5/20

Recall Number: D-0487-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6

Batch or Lot Expiration Information

Lot# : 16195, Exp 7/19; 16211, Exp 8/19; 16216, Exp 8/19

Recall Number: D-0419-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
3060 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 NDC 59390-217-02

Batch or Lot Expiration Information

Lot# 18164 7/20

Affected Packages Involved in this Recall

59390-217-02 Ciprofloxacin Hcl Ophthalmic
59390-217-05 Ciprofloxacin Hcl Ophthalmic
59390-217-10 Ciprofloxacin Hcl Ophthalmic

Recall Number: D-0395-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : QHE, Exp 08/19; QJD, Exp 10/19

Recall Number: D-0486-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g

Batch or Lot Expiration Information

Lot# : QJD, Exp 10/19; RFK, Exp 6/20; SCB, Exp 3/21; TBI, Exp 2/22

Recall Number: D-0366-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
469128 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49

Batch or Lot Expiration Information

Lot# : 17384, Exp 12/19; 17259, Exp 08/19; 19002, Exp 01/21; 19041, Exp 02/21; 18222, Exp 09/20; 18084, Exp 04/20

Recall Number: D-0396-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
222096 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 18043 2/20 18115 5/20 18300 12/20 18300 12/20 18116 5/20 18115 5/20 18044 2/20 18043 2/20

Recall Number: D-0440-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
81403 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05

Batch or Lot Expiration Information

Lot# 17186 6/20 17345 11/20 19010 1/22 17041 2/2020 16217 8/19

Recall Number: D-0376-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
531,936 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 17215 07/19 17239 08/19 18081 03/21 18207 08/20 18274 11/21

Recall Number: D-0434-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
4409 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-13

Batch or Lot Expiration Information

Lot# : 17366, Exp 12/19

Recall Number: D-0365-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
441792 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50

Batch or Lot Expiration Information

Lot# : SAJ, Exp 01/21; SFE, Exp 06/21; SIA, Exp 09/21; RIE, Exp 09/20; REH, Exp 05/20; RAD, Exp 01/20; TAH, Exp 01/22; TDD, Exp 04/22

Recall Number: D-0456-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 17238 08/19 18094 4/20 19058 02/21

Recall Number: D-0442-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
75996 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15

Batch or Lot Expiration Information

Lot# 17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22 16260 9/19

Recall Number: D-0443-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
9518 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01

Batch or Lot Expiration Information

Lot# 17217 7/19 11/10/2017 18256 10/20 17236 8/31/2019 17334 11 /30/2019 18015 1/31/2020

Recall Number: D-0489-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7

Batch or Lot Expiration Information

Lot# : 16192, Exp 7/19; 16203, Exp 7/19; 16242, Exp 9/19; 16280, Exp 10/19; 16285, Exp 10/19; 16300, Exp 11/19; 16336, Exp 12/19; 17002, Exp 1/20; 17012, Exp 1/20; 17051, Exp 2/20; 17130, Exp 04/20; 17147, Exp 05/20

Recall Number: D-0427-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
137 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-208-10

Batch or Lot Expiration Information

Lot# 19122 4/21

Recall Number: D-0467-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
20666 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15

Batch or Lot Expiration Information

Lot# 17282 9/19 18121 5/20

Recall Number: D-0415-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
306,479 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13

Batch or Lot Expiration Information

Lot# 17205 07/19 08/31/2017 17206 07/19 09/13/2017 17271 09/19 11/08/2017 18003 01/20 03/06/2018 18097 04/20 05/11/2018 18166 07/20 07/26/2018 18227 09/20 10/05/2018 18246 10/20 11/16/2018 18317 12/20 12/18/2018 19080 03/21 04/22/2019 19106 04/21

Recall Number: D-0387-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
238,968 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 17223 07/19 17297 10/19 18017 01/20 18018 01/20 18065 03/21 18213 08/20 18247 10/21

Recall Number: D-0435-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
12,716 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10

Batch or Lot Expiration Information

Lot# 17366 12/19 18103 /20 18173 7/20

Recall Number: D-0463-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
41925 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15

Batch or Lot Expiration Information

Lot# 17281 9/19 18120 5/20

Recall Number: D-0420-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
636 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10

Batch or Lot Expiration Information

Lot# 18164 7/20

Affected Packages Involved in this Recall

59390-217-02 Ciprofloxacin Hcl Ophthalmic
59390-217-05 Ciprofloxacin Hcl Ophthalmic
59390-217-10 Ciprofloxacin Hcl Ophthalmic

Recall Number: D-0450-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
81217 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15

Batch or Lot Expiration Information

Lot# 17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23

Recall Number: D-0472-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51

Batch or Lot Expiration Information

Lot# 17367 12/19 18174 7/20

Recall Number: D-0459-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
73,548 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707

Batch or Lot Expiration Information

Lot# 17131 5/20 18031 1/21 19065 3/22

Recall Number: D-0401-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 17238 08/19 18094 4/20 19058 02/21

Recall Number: D-0405-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
58,704 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# RIN 09/19 RKP 11/19 SAR 01/20 SCG 03/20 SED 5/20 SLC 12/20 TBE 02/21 TBL 02/21

Recall Number: D-0392-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
483528 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 17251 8/19 17269 9/19 17360 12/19 18012 1/20 18106 4/20 18275 11/20 18275 11/20

Recall Number: D-0404-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
48,168 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 17285 09/19 18067 03/20 18205 08/20 18067 3/20

Recall Number: D-0385-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : SAS 1/21 SIA 9/21 SFE 6/21 SAS 1/21 SFE 6/21 SIA 9/21 RIE 9/20 REH 5/20 RAD 1/20 TAH 1/22

Recall Number: D-0380-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
39,288 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 0805 Made in the USA 02895

Batch or Lot Expiration Information

Lot# : 17215 07/19 17239 08/19 18081 03/21 18207 08/20 18274 11/21

Recall Number: D-0478-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
6024 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05

Batch or Lot Expiration Information

Lot# : 18164, Exp 7/20

Affected Packages Involved in this Recall

59390-217-02 Ciprofloxacin Hcl Ophthalmic
59390-217-05 Ciprofloxacin Hcl Ophthalmic
59390-217-10 Ciprofloxacin Hcl Ophthalmic

Recall Number: D-0370-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
99420 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 563031654, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54

Batch or Lot Expiration Information

Lot# : RKP 11/19 RIN 09/19 SLC 12/20 RIF 09/19 TBE 02/21 TBI 02/21 SHB 08/20

Recall Number: D-0421-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
390 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-02

Batch or Lot Expiration Information

Lot# 17247 8/19

Affected Packages Involved in this Recall

59390-149-02 Diclofenac
59390-149-05 Diclofenac

Recall Number: D-0414-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
6,877 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50

Batch or Lot Expiration Information

Lot# SKG 11/21 12/28/2018 TAQ 01/22 04/23/2019

Recall Number: D-0441-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
88,008 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15

Batch or Lot Expiration Information

Lot# 17205 7/19 17206 7/19 18003 1/20 18097 4/20 18166 7/20 18292 11/20 19106 4/21

Recall Number: D-0403-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
39,744 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 17296 10/19 18094 04/20 18206 08/20

Recall Number: D-0418-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
161077 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50

Batch or Lot Expiration Information

Lot# RJH 10/20 1/10/2018 RLL 12/20 8/22/2018 SGH 07/21 8/23/2018 SIF 09/21 10/16/2018 SKC 11/21 12/12/2018 TCG 03/22

Affected Packages Involved in this Recall

59390-198-50 Altalube

Recall Number: D-0367-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
1537130 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50

Batch or Lot Expiration Information

Lot# : SKG,Exp 08/21; SHK, Exp 08/21; SHJ, Exp 08/21; SEC, Exp 05/21; SCB, Exp 03/21; SBC, Exp 02/21; RLB, Exp 12/20; RBB, Exp 02/20; RHR, Exp 08/20; RFK, Exp 06/20; RAB, Exp 01/20; TAD, Exp 01/22; TAQ, Exp 01/22; TBI, Exp 02/22; TDB, Exp 04/22; QHE, Exp 08/19; QJD, Exp 10/19; SGE, Exp 07/21

Recall Number: D-0363-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
45672 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Item #801486, NDC 0363-0191-50

Batch or Lot Expiration Information

Lot# : TDB, Exp 4/22

Recall Number: D-0437-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
88 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-148-52

Batch or Lot Expiration Information

Lot# 19015 1/21

Recall Number: D-0398-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
139572 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15

Batch or Lot Expiration Information

Lot# 16250 09/19 16268 10/19 16301 11/19 17088 3/20 17109 4/20 17318 10/20 17323 10/20 18014 1/21 18045 2/21 18059 3/21 18063 3/21 18117 5/21 18134 5/21

Recall Number: D-0424-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
414,346 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18

Batch or Lot Expiration Information

Lot# 17200 7/19 17322 10/20 18026 1/21 18100 4/21 18236 9/21 19052 2/22

Recall Number: D-0479-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
2870 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51

Batch or Lot Expiration Information

Lot# : 17367, Exp 12/19; 18174, Exp 7/20

Recall Number: D-0453-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
13626 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

Batch or Lot Expiration Information

Lot# : 18008 1/20 19105 4/22

Recall Number: D-0382-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
45864 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334,Product Size: 0.6 mL x 60 count, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : RGF, Exp 07/19; RHN, Exp 08/19; RIH, Exp 09/19; RJP, Exp 10/19; RKN, Exp 11/19; SDC Exp 04/20; SFC, Exp 06/20; SFJ, Exp 06/20; SGI, Exp 07/20

Recall Number: D-0412-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
222,096 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 18043 2/20 18115 5/20 18300 12/20 18300 12/20 18116 5/20 18115 5/20 18044 2/20 18043 2/20

Recall Number: D-0371-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
50,904 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item # 563031654, Package Size 7.5 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54

Batch or Lot Expiration Information

Lot# : 17290; Exp 09/19

Recall Number: D-0462-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
81969 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15

Batch or Lot Expiration Information

Lot# 17210 7/19 17378 12/19 18175 7/20

Recall Number: D-0364-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
557,376 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-189-49

Batch or Lot Expiration Information

Lot# : 17196, Exp 07/19; 17292, Exp 09/19; 17355, Exp 11/19; 19040, Exp 02/21

Recall Number: D-0457-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
90,072 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

Batch or Lot Expiration Information

Lot# 16250 09/19 17088 03/20 17307 10/20 17323 10/20 18014 1/21 18228 9/21 18261 10/21 19119 4/22

Recall Number: D-0445-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
14091 cartons.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01

Batch or Lot Expiration Information

Lot# 17236 8/19 17334 11/19 18015 1/20

Recall Number: D-0394-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 18229 9/21 18229 9/21 19056 03/22

Recall Number: D-0384-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
284,232 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : RJK 10/19 SBJ 2/20 SFG 6/20 SHI 8/20 SLB 12/20 TCM 03/21 TDC 4/21

Recall Number: D-0471-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
1,381,638 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
TRP Pink Eye Relief, 10 mL, NDC 17312-013-15

Batch or Lot Expiration Information

Lot# 17185 6/20 17228 7/20 17349 11/20 18073 3/21 18218 8/21 18303 12/21

Recall Number: D-0452-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
19632 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

Batch or Lot Expiration Information

Lot# : SAP 1/20 SFI 6/20 TCI 3/21

Recall Number: D-0439-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
48 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,NDC 59390-189-50

Batch or Lot Expiration Information

Lot# SFE 06/21

Recall Number: D-0465-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
41906 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-104-15

Batch or Lot Expiration Information

Lot# 17374 12/19 18196 8/20

Recall Number: D-0406-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
39,072 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# RHD 08/19 RIF 09/19 RIN 09/19 RKP 11/19 SAR 01/20 SCG 03/20 SED 5/20

Recall Number: D-0393-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
464424 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 18229 9/21 18031 1/21 17131 5/20 17059 3/20 17008 1/20 19056 03/22

Recall Number: D-0378-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
45,864 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, Item #495334, 60 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 31010 6

Batch or Lot Expiration Information

Lot# : RGF 07/19 RHN 08/19 RIH 09/19 RJP 10/19 RKN 11/19 SDC 04/20 SFC 06/20 SFJ 06/20 SGI 07/20

Recall Number: D-0410-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
483,528 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz., (15 mL), Item #994880, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 17251 8/19 17269 9/19 17360 12/19 18012 1/20 18106 4/20 18275 11/20 18275 11/20

Recall Number: D-0458-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
90072 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

Batch or Lot Expiration Information

Lot# 18095 4/20

Recall Number: D-0473-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
273,100 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35

Batch or Lot Expiration Information

Lot# RJH 10/19 SCC 3/21 SGA 7/21 SGH 7/21 SHH 8/21 SLL 12/21 TAC 1/22

Recall Number: D-0433-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
1,666 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-49

Batch or Lot Expiration Information

Lot# 18033 2/20

Recall Number: D-0482-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77

Batch or Lot Expiration Information

Lot# : 18008 1/20 19105 4/22

Recall Number: D-0481-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
19632 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76

Batch or Lot Expiration Information

Lot# : SAP 1/20 3/16/2018 SFI 6/20 10/29/2018 TCI 3/21

Recall Number: D-0409-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
37656 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 17291 9/19 17385 12/19 18118 5/20

Recall Number: D-0386-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
159,864 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 19087 3/21 17289 9/19 19087 03/21 18122 5/20

Recall Number: D-0444-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
103856 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05

Batch or Lot Expiration Information

Lot# : 17198, Exp 7/19; 17199, Exp 7/19; 17233, Exp 8/19; 17337, Exp 11/19; 17338, Exp 11/19; 18248, Exp 10/20

Recall Number: D-0449-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
427,280 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21

Batch or Lot Expiration Information

Lot# 17255 8/20 17362 12/20 18089 4/21 18138 6/21 6/22/2018 18146 6/21 18210 8/21 18211 8/21 18272 11/21 18273 11/21 18276 11/21 16283 10/31/2019

Recall Number: D-0480-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51

Batch or Lot Expiration Information

Lot# : 17366, Exp 12/19

Recall Number: D-0470-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
318,412 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
TRP Stye Relief, 4 g, NDC 17312-014-13

Batch or Lot Expiration Information

Lot# RHP 8/19 RLD 12/19 SDE 4/20 SID 9/20

Recall Number: D-0475-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52

Batch or Lot Expiration Information

Lot# 19015 01/21 19117 04/21 18080 07/20 18111 05/20

Recall Number: D-0390-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
109,020 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : QHF 08/19 QHI 08/19 QLA 12/19 RBA 02/20 RCF 03/20 RCM 03/20 RDJ 04/20 RFA 06/20 RHI 08/20 RJI 10/20 RKG 11/20 RLE 12/20 SAW 01/21 SBF 02/21

Recall Number: D-0369-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
259104 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-885-49

Batch or Lot Expiration Information

Lot# : 19137 05/22 19022 01/22

Recall Number: D-0368-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
55772 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size: 3.5g and 15mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-883-59

Batch or Lot Expiration Information

Lot# : KT19146 02/21 06/05/2019 KT18133 04/20 12/12/2018 KT18194 07/20 01/15/2019 KT18129 02/20

Recall Number: D-0469-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
24144 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
TRP Blur Relief, 15 mL, NDC 17312-002-11

Batch or Lot Expiration Information

Lot# 16256 09/19 17194 7/20

Recall Number: D-0360-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15 mL, NDC 0363-0185-49

Batch or Lot Expiration Information

Lot# : 19095, Exp 04/21

Recall Number: D-0372-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
17,613 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.)

Batch or Lot Expiration Information

Lot# : 17290, Exp 09/19; 19011, Exp 01/21; 18052, Exp 02/20; 18266, Exp 10/20; 18178, Exp07/20; 17385, Exp 12/19

Recall Number: D-0477-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 16267, Exp 10/19; 18096, Exp 04/21; 18301, Exp 12/21; 18096, Exp 4/21; 18301, Exp 12/21; 17371, Exp 12/20; 17158, Exp 6/20; 17025, Exp 1/20; 17015, Exp 1/20; 19103, Exp 04/22

Recall Number: D-0490-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7

Batch or Lot Expiration Information

Lot# : 16321, Exp 11/19; 16336, Exp 12/19; 17012, Exp 1/20; 17034, Exp 2/20; 17051, Exp 2/20; 17147, Exp 5/20

Recall Number: D-0485-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
73548 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL

Batch or Lot Expiration Information

Lot# : 17008, Exp 01/20

Recall Number: D-0388-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
39,744 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item #994881 Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 17296 10/19 18094 04/20 18206 08/20

Recall Number: D-0476-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
114504 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# SEI 5/20 TAK 01/21

Recall Number: D-0428-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
2,392 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390- 145-10

Batch or Lot Expiration Information

Lot# 18052 2/20

Recall Number: D-0383-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
39072 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Containers, 0.02 FL OZ (0.6 mL) EACH, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : RGF 07/19 RHN 08/19 RIH 09/19 RJP 10/19 RKN 11/19 SDC 04/20 SFC 06/20 SFJ 06/20 SGI 07/20 SKF 11/20 TAE 01/21

Recall Number: D-0402-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
159864 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# 19087 3/21 17289 9/19 19087 03/21 18122 5/20

Recall Number: D-0399-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
2,042,136 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13

Batch or Lot Expiration Information

Lot# 19128 05/21 19009 01/21 19003 01/21 19034 01/21 19060 02/21 19061 02/21 18252 10/20 18058 03/20 18224 09/20 18185 07/20 18152 06/20 18159 06/20 18091 04/20 18090 04/20 18069 03/20

Recall Number: D-0377-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-02-2019
Reported
11-27-2019
Quantity
101,712 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# : 17277 09/19 18006 01/20 18098 04/21 18006 1/20 19057 02/22