FDA Drug recall D-1117-2015
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
- FDA Drug
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT by Montana Compounding Pharmacy, citing lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1117-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-15 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Montana Compounding Pharmacy |
| Distribution | MT, ND |
Product
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Identifiers
| code_info | Lot 03252015:61@6, expiry date: 7/23/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1117-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.