Drug product
VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy
D-0784-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 vials
- Official record key
drug-enforcement:D-0784-2017
Official wording
Reason: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Code information: Lot # t02-03-2017@37, Exp 5/7/2017
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility