Drug product
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
D-0209-2017
Product summary
- Event
- Event 74286
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0209-2017
Official wording
Reason: Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Code information: All lots with Use by Date of 5/22/2016 to 8/31/2016
Distribution pattern: NJ and NY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility