Drug product
HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.
D-0722-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 vials total (10/1mL vials and 40/2mL vials)
- Official record key
drug-enforcement:D-0722-2017
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 # t01-17-2017@103, Exp 4/18/2017; t01-23-2017@80, Exp 4/24/2017; t02-10-2017@120, Exp 4/30/2017.
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility