Drug product
Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.
D-1125-2015
Product summary
- Event
- Event 71275
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32/2 mL vials
- Official record key
drug-enforcement:D-1125-2015
Official wording
Reason: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Code information: Lot 02112015:78@15, expiry dates: 6/1/2015; Lot 04062015:03@9, expiry dates: 6/8/2015
Distribution pattern: MT and ND
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility