Drug product
EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.
D-0959-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,570 bags
- Official record key
drug-enforcement:D-0959-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-240224, Exp. 7/16/2023; 36-242322, EXP. 7/24/2023; 36-242445, Exp. 7/25/2023; 36-243305, Exp. 7/27/2023; 36-243813, Exp. 7/31/2023; 36-246166, 36-246167, Exp. 8/3/2023; 36-247670, Exp. 8/9/2023; 36-248992, Exp.8/16/2023; 36-249468, Exp. 8/17/2023; 36-249590, Exp.8/18/2023; 36-251336, 36-251644, Exp. 8/27/2023; 36-251461, Exp. 8/28/2023; 36-255531, 36-255532, Exp. 9/7/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility