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.
This recall has been terminated (originally issued December 14, 2016).
- 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
- Official Source
- View on FDA website ↗
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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