Drug product
vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.
D-0718-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3075 bags
- Official record key
drug-enforcement:D-0718-2023
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 # 37-884161, Exp 05/03/2023; 37-885995, 37-885997, Exp 05/10/2023; 37-887729, Exp 05/17/2023; 37-889595, Exp 05/24/2023; 37-891272, Exp 05/31/2023; 37-892162, Exp 06/05/2023; 37-894716, Exp 06/14/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility