Drug product
HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
D-0720-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 vials
- Official record key
drug-enforcement:D-0720-2017
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 # 01-20-2017@74, Exp 4/20/2017; t02-01-2017@123, Exp 5/3/2017; t02-03-2017@47, Exp 5/7/2017; t02-07-2017@70, Exp 5/10/2017; t02-13-2017@100, Exp 5/15/2017.
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility