FDA recall D-0370-2022

Teva Pharmaceuticals USA · Class II · drug

Product

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

Distribution

Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

Key facts

Status
Terminated
Initiation date
2021-12-31
Report date
2022-01-19
Termination date
2024-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0370-2022