Piramal Critical Care, Inc. recalls Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, D…

Recall date

July 8, 2019

Source

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

Recall number

D-1742-2019

FDA classification

Class II

Brand / firm

Piramal Critical Care, Inc.

Sold / distributed

USA Nationwide

Why it was recalled

Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.

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

What was recalled

Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01