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Recall Observatory FDA recall evidence

Drug product

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1126-2015

May 15, 2015

Class II

Product summary

Firm
Montana Compounding Pharmacy
Event
Event 71275
Status
Terminated
Classification
Class II
Quantity
25/5 mL. vials
Official record key
drug-enforcement:D-1126-2015

Official wording

Reason: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Code information: Lot 03112015:17@5; Expiry date: 6/1/2015; Lot 04042015:61@2; Expiry date: 6/3/2015; Lot 05022015:11@2; Expiry date: 6/16/2015;

Distribution pattern: MT and ND

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility