Fallon Wellness Pharmacy, L.L.C. recalls PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pha
Recalled December 14, 2016 · FDA recall D-0174-2017 · Fallon Wellness Pharmacy, L.L.C
Hazard
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. · FDA Class II
Units
5 vials
Sold at
NY
Description
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
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.
Manufacturer(s)
Fallon Wellness Pharmacy, L.L.C.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →