Drug product
FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
D-0719-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 vials total (3/2mL vials and 9/10mL vias)
- Official record key
drug-enforcement:D-0719-2017
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 # t01-31-2017@128, Exp 5/2/2017; 01-31-2017@118, Exp 5/1/2017.
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility