D-1117-2015 Class II Terminated

Recalled by Montana Compounding Pharmacy — Missoula, MT

Recall Details

Product Type
Drugs
Report Date
June 17, 2015
Initiation Date
May 15, 2015
Termination Date
December 20, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1/5mL vial

Product Description

Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Reason for Recall

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

Distribution Pattern

MT and ND

Code Information

Lot 03252015:61@6, expiry date: 7/23/2015