Drug product
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.
D-1120-2015
Product summary
- Event
- Event 71275
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1/5mL vial
- Official record key
drug-enforcement:D-1120-2015
Official wording
Reason: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Code information: Lot 04102015:18@15, expiry date: 7/3/2015
Distribution pattern: MT and ND
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility