FDA recall D-1128-2015

Product

Alprostadil (PFE1), solution, 30 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

MT and ND

Key facts

Status

Terminated

Initiation date

2015-05-15

Report date

2015-06-17

Termination date

2016-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Missoula, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1128-2015