Recalls / Class II

Class IID-1127-2015

Product

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Affected lot / code info

Lot 04082015:49@7; expiry date: 6/18/2015; Lot 04222015:25@8; expiry date: 7/3/2015.

Why it was recalled

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

Recalling firm

Firm

Montana Compounding Pharmacy

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

111 N Higgins Ave, N/A, Missoula, Montana 59802-4437

Distribution

Quantity

2/5 mL vials

Distribution pattern

MT and ND

Timeline

Recall initiated

2015-05-15

FDA classified

2015-06-09

Posted by FDA

2015-06-17

Terminated

2016-12-20

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1127-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.