FDA recall D-0174-2017

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.

Distribution

NY

Key facts

Status

Terminated

Initiation date

2016-11-02

Report date

2016-12-14

Termination date

2018-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Latham, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2017