Phenotolamine 0 recalled over sterility concerns

Recall date

September 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Apothecary Shoppe LLC recalls Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

Recall number

D-0003-2017

FDA classification

Class II

Brand / firm

The Apothecary Shoppe LLC

Sold / distributed

Oklahoma

Why it was recalled

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK