Drug product
oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6032-1.
D-0703-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2624 bags
- Official record key
drug-enforcement:D-0703-2023
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 # 37-883948, Exp 05/02/2023; 37-886037, 37-886040, Exp 05/10/2023; 37-889593, Exp 05/24/2023; 37-891270, Exp 05/31/2023; 37-893223, Exp 06/08/2023; 37-896230, Exp 06/20/2023; 37-898520, Exp 06/29/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility