Teva Pharmaceuticals USA recalls MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pha
Recalled March 3, 2021 · FDA recall D-0284-2021 · Teva Pharmaceuticals USA
Hazard
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. · FDA Class II
Units
15,043 vials
Sold at
Product was distributed nationwide in the USA and Puerto Rico.
Description
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.
Product
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →