Drug product
Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
D-1124-2015
Product summary
- Event
- Event 71275
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1/1 mL. vial
- Official record key
drug-enforcement:D-1124-2015
Official wording
Reason: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Code information: Lot 04162015:77@4, Expiry date: 6/8/2015
Distribution pattern: MT and ND
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility