December 16, 2016
Fallon Wellness Pharmacy, LLC, is recalling 10 1-mL vials of PAPA/PHEN/PROST (papaverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, according to the US Food and Drug Administration (FDA) Enforcement Report for the week of December 14.
Drugs with the following code information were recalled due to uncertain sterility: Lot #: 09192016@41,09192016@69, Exp 11/04/2016. The vials were distributed throughout New York.
The impacted product was “produced on a day there was an excursion in environmental monitoring data,” according to the FDA report.
The recall was voluntary and was initiated by Fallon Wellness Pharmacy last month. It is currently in progress.
The FDA gave the recall a Class II designation on December 8. A Class II recall involves products that “might cause a temporary health problem, or pose only a slight threat of a serious nature,” as described on the Enforcement Report Definitions page.--Meredith Edwards White
Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published December 14, 2016. Accessed December 16, 2016.