Drug product
oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6036-1.
D-0704-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2989 bags
- Official record key
drug-enforcement:D-0704-2023
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 # 37-891283, Exp 05/06/2023; 37-892501, Exp 05/12/2023; 37-894413, Exp 05/19/2023; 37-896228, Exp 05/26/2023; 37-896815, 37-896820, 37-896826, Exp 05/28/2023; 37-900126, Exp 06/10/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility