FDA recall D-0312-2015

Product

Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Reason for recall

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Distribution

KY

Key facts

Status

Terminated

Initiation date

2014-10-14

Report date

2014-12-31

Termination date

2015-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Glasgow, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0312-2015