Drug product
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
D-1127-2015
Product summary
- Event
- Event 71275
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2/5 mL vials
- Official record key
drug-enforcement:D-1127-2015
Official wording
Reason: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Code information: Lot 04082015:49@7; expiry date: 6/18/2015; Lot 04222015:25@8; expiry date: 7/3/2015.
Distribution pattern: MT and ND
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility