Drug product
vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.
D-0717-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4390 bags
- Official record key
drug-enforcement:D-0717-2023
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 # 37-885351, Exp 05/08/2023; 37-885979, Exp 05/10/2023; 37-887721, Exp 05/17/2023; 37-889212, Exp 05/23/2023; 37-889607, Exp 05/24/2023; 37-891247, Exp 05/31/2023; 37-892937, Exp 06/07/2023; 37-894025, Exp 06/12/2023; 37-894748, Exp 06/14/2023; 37-895282, Exp 06/18/2023; 37-896173, Exp 06/20/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility