Drug product
phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
D-0962-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,853 bags.
- Official record key
drug-enforcement:D-0962-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-249691, 36-249692, Exp. 8/20/2023; 36-250052, 36-250053, Exp. 8/22/2023; 36-251062, Exp. 8/24/2023; 36-251992, Exp. 8/30/2023; 36-252467, Exp. 9/3/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility