Recalls / Class II
Class IID-0371-2022
Product
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
- Affected lot / code info
- Lot # 100020800, exp 07/2022
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
- 11,450 vials
- Distribution pattern
- Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Timeline
- Recall initiated
- 2021-12-31
- FDA classified
- 2022-01-13
- Posted by FDA
- 2022-01-19
- Terminated
- 2024-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0371-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.