Drug product
TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
D-0739-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0739-2017
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 # t12-12-2016@84, Exp 5/22/2017
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility