Drug product
5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
D-0707-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 vials
- Official record key
drug-enforcement:D-0707-2017
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 # t11-21-2016@112, Exp 5/21/2017; 12-15-2016@73, Exp 6/13/2017; 01-13-2017@67, Exp 7/12/2017; t02-14-2017@97, Exp 8/14/2017
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility