Drug product
vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
D-0736-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8252 bags
- Official record key
drug-enforcement:D-0736-2023
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 # 37-884152, 37-884158, Exp 05/03/2023; 37-885300, 37-885302, 37-885307, Exp 05/08/2023; 37-887418, 37-887431, 37-887432, Exp 05/16/2023; 37-888850, 37-888852, 37-888853, Exp 05/22/2023; 37-889188, Exp 05/23/2023; 37-890892, 37-890894, 37-890897, Exp 05/30/2023; 37-891232, Exp 05/31/2023; 37-892014, 37-892017, Exp 06/05/2023; 37-894411, 37-894412, 37-894414, Exp 06/13/2023; 37-894659, Exp 06/14/2023; 37-896078, 37-896089, 37-896097, Exp 06/20/2023; 37-897369, Exp 06/26/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility