FDAFDA · Food and drugs·Recall number D-0282-2021
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.
Published March 3, 2021 · Recall initiated: February 10, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Product was distributed nationwide in the USA and Puerto Rico.
- Lot
- Lot # 31327725B, exp. date 02/2021 Lot # 31327906B, exp. date 03/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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