FDA Drug recall D-0174-2017
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy…
- FDA Drug
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy… by Fallon Wellness Pharmacy, citing lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0174-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-02 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fallon Wellness Pharmacy |
| Distribution | NY |
Product
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Reason
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Identifiers
| code_info | Lot #: 09202016@8, Exp 11/04/2016 |
|---|
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-0174-2017%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.