FDA recall D-0376-2021

Teva Pharmaceuticals USA · Class II · drug

Product

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed nationwide.

Key facts

Status
Terminated
Initiation date
2021-04-26
Report date
2021-05-26
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-0376-2021