MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/ recalled over sterility concerns

Recall date

December 31, 2021

Source

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

Official notice title

Teva Pharmaceuticals USA recalls MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufact…

Recall number

D-0370-2022

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

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

MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.