FDA Drug recall D-0173-2017
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 T…
- 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) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 T… 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-0173-2017 |
| 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) 18 mg/0.6 mg/0.006 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 #: 09192016@41,09192016@69, 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.
Other recalls by Fallon Wellness Pharmacy
- 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 · 2016-12-14 · Fallon Wellness Pharmacy - Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy - Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy - Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection…
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy - Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
All Fallon Wellness Pharmacy recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0173-2017%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.