Recalls / Class II
Class IID-0281-2021
Product
MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Affected lot / code info
- Lot # 31327909B, exp. date 04/2021 Lot # 31328352B, exp. date 07/2021
Why it was recalled
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 5,378 vials
- Distribution pattern
- Product was distributed nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2021-02-10
- FDA classified
- 2021-02-21
- Posted by FDA
- 2021-03-03
- Terminated
- 2024-05-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0281-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.