FDA Drug Class II — Moderate

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.

Hazard

Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.

Products

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.
Brand
Fallon Wellness Pharmacy, L.L.C.
UPC
Lot #: 09202016@8, Exp 11/04/2016

Units Affected

5 vials