Drug product
PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
D-0960-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7518 bag
- Official record key
drug-enforcement:D-0960-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-239333, Exp. 7/11/2023; 36-240005, Exp. 7/13/2023; 36-240800, Exp. 7/17/2023; 36-241139, 36-241140, Exp. 7/19/2023; 36-241913, Exp.7/23/2023; 36-242557, 36-242560, Exp. 7/25/2023; 36-244880, 36-244883, 36-244884, 36-244885, Exp. 8/1/2023; 36-246717, 36-246718, 36-246719, 36-246720, Exp.8/6/2023; 36-247598, 36-247599, Exp. 8/9/2023; 36-247828, 36-247829, 36-247830, 36-247831, Exp. 8/10/2023; 36-249233, 36-249234, 36-249235, 36-249344, Exp. 8/17/2023; 36-255964, Exp. 9/10/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility