RecallDepth
Class II Terminated

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.

Company
Fallon Wellness Pharmacy, L.L.C.
Recall Initiated
November 2, 2016
Posted
December 14, 2016
Recall Number
D-0174-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
5 vials
Firm Location
Latham, NY, United States

Reason for Recall

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

Distribution

NY

Lot / Code Info

Lot #: 09202016@8, Exp 11/04/2016

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