Multi-event July 2019 FDA Recall Drug by Colonia Care Pharmacy
This Multi-event Class II drug recall was voluntarily initiated by Colonia Care Pharmacy on July 24, 2019 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Patient Specific Prescriptions in NJ and the recall is currently terminated.
Reported Recall Events
D-0026-2020 D-0005-2020 D-0014-2020 D-0011-2020 D-0022-2020 D-0008-2020 D-0007-2020 D-0004-2020 D-0010-2020 D-0003-2020 D-0032-2020 D-0012-2020 D-0025-2020 D-0029-2020 D-0034-2020 D-0024-2020 D-0020-2020 D-0006-2020 D-0028-2020 D-0023-2020 D-0015-2020 D-0009-2020 D-0027-2020 D-0018-2020 D-0033-2020 D-0030-2020 D-0017-2020 D-0016-2020 D-0031-2020 D-0019-2020 D-0013-2020 D-0021-2020
Recall Number: D-0026-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 071819H, BUD 09/01/19
Recall Number: D-0005-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
12 droptainer bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070119A, BUD 08/15/19; 072219N, BUD 09/05/19
Recall Number: D-0014-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
18 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 041119A, BUD 10/08/19; 051019J, BUD 11/6/19; 070519C, BUD 01/01/20
Recall Number: D-0011-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070319J, BUD 08/17/19
Recall Number: D-0022-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 071519E, BUD 08/29/19
Recall Number: D-0008-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
60 nebulizer vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070219B, BUD 08/06/19
Recall Number: D-0007-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 071119C, BUD 08/25/19
Recall Number: D-0004-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 droptainer bottle
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 071819E, BUD 09/01/19
Recall Number: D-0010-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 droptainer vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 072219B, BUD 08/05/19
Recall Number: D-0003-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
2 droptainer bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : a) 070819A, BUD 08/22/19; b) 071619F, BUD 08/30/19
Recall Number: D-0032-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 droptainer bottle
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 071019B, BUD 08/09/19
Recall Number: D-0012-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
30 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 062619E, BUD 08/10/19
Recall Number: D-0025-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 072219A, BUD 09/05/19
Recall Number: D-0029-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 072419B, BUD 09/07/19
Recall Number: D-0034-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 072319A, BUD 09/06/19
Recall Number: D-0024-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
7 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : a) and b) 070519A, BUD 08/19/19
Recall Number: D-0020-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 071619J, BUD 08/30/19
Recall Number: D-0006-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 droptainer bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 071619D, BUD 08/30/19
Recall Number: D-0028-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 062419B, BUD 08/08/19
Recall Number: D-0023-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 062719E, BUD 08/11/19
Recall Number: D-0015-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 droptainer bottle
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070819B, BUD 08/07/19
Recall Number: D-0009-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
37 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070319G, BUD 08/17/19; 071219P, BUD 08/26/19
Recall Number: D-0027-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 062419C, BUD 08/08/19
Recall Number: D-0018-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
191 syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 020719A, BUD 08/06/19; 051619E, BUD 11/12/19
Recall Number: D-0033-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
7 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 062719A, BUD 08/11/19
Recall Number: D-0030-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070319A, BUD 08/17/19
Recall Number: D-0017-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
15 syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070919C, BUD 08/23/19
Recall Number: D-0016-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
6 syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 071819C, BUD 09/01/19
Recall Number: D-0031-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070319F, BUD 08/17/19
Recall Number: D-0019-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
6 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : a) and b) 071119E, BUD 08/25/19
Recall Number: D-0013-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
15 syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 070919E, BUD 08/23/19
Recall Number: D-0021-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
07-24-2019
10-09-2019
2 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Colonia Care Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Patient Specific Prescriptions in NJ
04-05-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Batch or Lot Expiration Information
Lot# : 072419C, BUD 09/07/19; 071519D, BUD 08/29/19
