PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL via...
FDA Recall #D-0174-2017 — Class II — November 2, 2016
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Recalling Firm
Fallon Wellness Pharmacy, L.L.C. — Latham, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5 vials
Distribution
NY
Code Information
Lot #: 09202016@8, Exp 11/04/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated