MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose V...

FDA Recall #D-0370-2022 — Class II — December 31, 2021

Recall #D-0370-2022 Date: December 31, 2021 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Teva Pharmaceuticals USA — Parsippany, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

7,400 cartons

Distribution

Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

Code Information

Lot # 100022393, exp 09/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated