Multi-event July 2016 FDA Recall Drug by Colonia Care Pharmacy
This Multi-event Class II drug recall was voluntarily initiated by Colonia Care Pharmacy on July 28, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.. The product was distributed in NJ and NY and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0208-2017
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
07-28-2016
12-28-2016
ALL
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NJ and NY
12-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Batch or Lot Expiration Information
Lot# All lots with Use by Date of 5/22/2016 to 8/31/2016
Recall Number: D-0209-2017
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
07-28-2016
12-28-2016
N/A
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NJ and NY
12-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Batch or Lot Expiration Information
Lot# All lots with Use by Date of 5/22/2016 to 8/31/2016
