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.
FDA recall notice · announced December 14, 2016 · Fallon Wellness Pharmacy
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Notes
Distribution: NY
Lot/code information: Lot #: 09202016@8, Exp 11/04/2016
Quantity: 5 vials
Status: Terminated
Products in this recall event:
- 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. (D-0173-2017)
- 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. (D-0174-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.