Multi-event September 2023 FDA Recall Major Lubrifresh Pm by Amman Pharmaceutical Industries

This Multi-event Class II drug recall was voluntarily initiated by Amman Pharmaceutical Industries on September 1, 2023 for the product Major Lubrifresh Pm. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was distributed to two (2) direct accounts in RI and CO. and the recall is currently ongoing.

Reported Recall Events

D-1155-2023 ONGOING D-1165-2023 ONGOING D-1162-2023 ONGOING D-1153-2023 ONGOING D-1164-2023 ONGOING D-1159-2023 ONGOING D-1151-2023 ONGOING D-1163-2023 ONGOING D-1158-2023 ONGOING D-1152-2023 ONGOING D-1156-2023 ONGOING D-1154-2023 ONGOING D-1166-2023 ONGOING D-1161-2023 ONGOING D-1157-2023 ONGOING D-1167-2023 ONGOING D-1160-2023 ONGOING

Recall Number: D-1155-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
196,111 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15.

Batch or Lot Expiration Information

Lot# Lot: IX001 EXP: 07/24; Lot: IX002 EXP: 12/24

Recall Number: D-1165-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
180,315 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.

Batch or Lot Expiration Information

Lot# Lot:182002 EXP: 11/24; Lot:182003 EXP: 11/24; Lot:182004 EXP: 12/24; Lot:182005 EXP:02/25; Lot:182006 EXP:02/25; Lot:182007EXP:02/25; Lot:182008 EXP:02/25; Lot:182009 EXP:02/25; Lot:182010 EXP:03/25: Lot:182011 EXP:03/25

Recall Number: D-1162-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
8,873

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19.

Batch or Lot Expiration Information

Lot# Lot: FP001 EXP:07/24

Recall Number: D-1153-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
8,810 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.

Batch or Lot Expiration Information

Lot# Lot: FT001; EXP: 07/24

Recall Number: D-1164-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
196,442 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.

Batch or Lot Expiration Information

Lot# Lot: IW001 EXP:07/24; Lot: IW002 EXP: 12/24

Recall Number: D-1159-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
18,171 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.

Batch or Lot Expiration Information

Lot# Lot: DA001 EXP: 06/24; Lot: DA002 EXP: 11/24

Recall Number: D-1151-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
8,747 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.

Batch or Lot Expiration Information

Lot# :DB001 EXP: 06/24

Recall Number: D-1163-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
8,868 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15.

Batch or Lot Expiration Information

Lot# Lot: FQ001 EXP:07/24

Recall Number: D-1158-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
16,500 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.

Batch or Lot Expiration Information

Lot# Lot: 180001 EXP: 01/25

Recall Number: D-1152-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
8,747

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.

Batch or Lot Expiration Information

Lot# Lot: IY001; EXP 07/24

Recall Number: D-1156-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
83,898 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19.

Batch or Lot Expiration Information

Lot# Lot: FR001 EXP: 07/24; Lot: FR004 EXP: 04/25; Lot:FR005 EXP: 04/25; Lot:FR006 EXP: 04/25; Lot: FR007 Exp: 04/25

Recall Number: D-1154-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
5,509

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.

Batch or Lot Expiration Information

Lot# Lot: DC001 EXP: 06/24

Recall Number: D-1166-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
8,819

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15.

Batch or Lot Expiration Information

Lot# Lot:DD001 EXP: 07/24

Recall Number: D-1161-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
293,400 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15.

Batch or Lot Expiration Information

Lot# Lot: IV001 EXP:06/25; Lot:IV002 EXP: 11/24; Lot:IV004 EXP:01/25

Recall Number: D-1157-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
8,000 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.

Batch or Lot Expiration Information

Lot# Lot: FV005 EXP:03/25

Recall Number: D-1167-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
30,490 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.

Batch or Lot Expiration Information

Lot# Lot: YM308 EXP:10/24

Recall Number: D-1160-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-01-2023
Reported
09-27-2023
Quantity
282,564 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92974
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMMAN PHARMACEUTICAL INDUSTRIES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two (2) direct accounts in RI and CO.
Product Description About Product Description
Full technical description of the product.
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.

Batch or Lot Expiration Information

Lot# Lot: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24

Affected Packages Involved in this Recall

0904-6488-38 Major Lubrifresh Pm