Recalls / Class II
Class IID-0209-2017
Product
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
- Affected lot / code info
- All lots with Use by Date of 5/22/2016 to 8/31/2016
Why it was recalled
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Recalling firm
- Firm
- Colonia Care Pharmacy
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 515 Inman Ave Ste A, N/A, Colonia, New Jersey 07067-1114
Distribution
- Quantity
- N/A
- Distribution pattern
- NJ and NY
Timeline
- Recall initiated
- 2016-07-28
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2023-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0209-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.