Drug product
EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
D-0958-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,784 bags
- Official record key
drug-enforcement:D-0958-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-239245, Exp. 7/10/2023; 36-241047, Exp. 7/18/2023; 36-241440, 36-241441, 36-241442, Exp. 7/20/2023; 36-242432, Exp. 7/25/2023; 36-243662, Exp. 7/30/2023; 36-246152, 36-246153, 36-246158, Exp. 8/3/2023; 36-246730, 36-246731, 36-246732, Exp. 8/6/2023; 36-247332, 36-247334, 36-247337, Exp. 8/8/2023; 36-249469, Exp. 8/17/2023; 36-249589, Exp. 8/18/2023; 36-250300, Exp. 8/23/2023; 36-251335, Exp. 8/27/2023; 36-254370, Exp. 9/4/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility