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.

Recall Number: D-0173-2017

Firm: Fallon Wellness Pharmacy, L.L.C.

Classification: Class II

Status: Terminated

Report Date: 20161214

Initiation Date: 20161102

Termination Date: 20180619

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

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.