Drug product
oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6043-1.
D-0709-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5544 bags
- Official record key
drug-enforcement:D-0709-2023
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 # 37-883938, Exp 05/02/2023; 37-884910, 37-884915, Exp 05/07/2023; 37-886041, Exp 05/10/2023; 37-887515, 37-887520, Exp 05/16/2023; 37-888318, Exp 05/21/2023; 37-888847, Exp 05/22/2023; 37-890535, Exp 05/29/2023; 37-890957, Exp 05/30/2023; 37-891566, 37-891568, Exp 06/01/2023; 37-892156, Exp 06/05/2023; 37-893165, 37-893166, Exp 06/08/2023; 37-893994, 37-893995, Exp 06/12/2023; 37-895771, 37-895773, 37-895775, Exp 06/19/2023; 37-896614, Exp 06/21/2023; 37-900377, Exp 07/06/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility