FDA recall D-0282-2021

Teva Pharmaceuticals USA · Class II · drug

Product

MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (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: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Distribution

Product was distributed nationwide in the USA and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2021-02-10
Report date
2021-03-03
Termination date
2024-05-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0282-2021