Drug product
vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6076-1.
D-0722-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9037 bags
- Official record key
drug-enforcement:D-0722-2023
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 # 37-883390, 37-883435, Exp 05/01/2023; 37-884157, Exp 05/03/2023; 37-885716, 37-886036, 37-886039, Exp 05/09/2023; 37-887499, 37-887500, Exp 05/16/2023; 37-887778, Exp 05/17/2023; 37-888105, Exp 05/18/2023; 37-889216, Exp 05/23/2023; 37-890923, 37-890928, 37-890936, Exp 05/30/2023; 37-891271, Exp 05/31/2023; 37-892649, Exp 06/06/2023; 37-892962, Exp 06/07/2023; 37-893966, 37-893967, 37-893969, 37-893998, Exp 06/12/2023; 37-896160, 37-896162, 37-896171, Exp 06/20/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility