Drug product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
D-0708-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3865 bags
- Official record key
drug-enforcement:D-0708-2023
Official wording
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Code information: Lot # 37-883926, Exp 05/02/2023; 37-886032, Exp 05/10/2023; 37-887681, Exp 05/17/2023; 37-888317, Exp 05/21/2023; 37-890906, Exp 05/30/2023; 37-892146, Exp 06/05/2023; 37-892507, Exp 06/06/2023; 37-894483, Exp 06/13/2023; 37-896595, Exp 06/21/2023; 37-898568, Exp 06/29/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility