Recalls / Class II
Class IID-0376-2021
Product
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
- Affected lot / code info
- Lot # 31327989B, exp. date 04/2021
Why it was recalled
Lack of Assurance of Sterility
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
- 7,564/1 multiple dose vial per carton
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-04-26
- FDA classified
- 2021-05-14
- Posted by FDA
- 2021-05-26
- Terminated
- 2024-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0376-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.