Drug product
CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
D-0760-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0760-2017
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 # t02-06-2017@107, Exp 4/30/2017 Lot t02-06-2017@107, Expiry date 4/30/2017
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility