FDANovember 2, 2016drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

fallon wellness pharmacyfallonfallon wellness

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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