FDA-Drug2021-03-03Class II
Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
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.
Sold states
Product was distributed nationwide in the USA and Puerto Rico.
Affected count
26,373 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0273-2021Don't want to check this manually?
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