Baclofen recalled over sterility concerns

Recall date

December 29, 2015

Source

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

Official notice title

TexasStar Pharmacy recalls Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023

Recall number

D-0733-2016

FDA classification

Class II

Brand / firm

TexasStar Pharmacy

Sold / distributed

TX

Why it was recalled

Lack of assurance of sterility

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

What was recalled

Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023