Drug product
oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.
D-0740-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2186 bags
- Official record key
drug-enforcement:D-0740-2023
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 # 37-886265, Exp 05/11/2023; 37-886266, Exp 05/11/2023; 37-889903, Exp 05/25/2023; 37-890551, Exp 05/29/2023; 37-892521, 37-892620, Exp 06/06/2023; 37-896246, 37-896247, Exp 06/20/2023; 37-898553, Exp 06/29/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility