PAPA/PHEN/PROST — Class II drug recall D-0174-2017
Terminated recall by Fallon Wellness Pharmacy, L.L.C., reported 2016-12-14, distributed in NY. Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring d
| Recall number | D-0174-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fallon Wellness Pharmacy, L.L.C., Latham, NY, United States |
| Recall initiated | 2016-11-02 |
| Classified | 2016-12-08 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2018-06-19 |
| Distributed | NY |
| Quantity | 5 vials |
| Reason classes | sterility |
| Expiration dates | 2016-11-04 |
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 for recall
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0174-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.