Recalls / Class II
Class IID-0735-2021
Product
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
- Affected lot / code info
- Lot #: 31325960B, exp. date12/2021; 31326111B, exp. date 01/2022; 31326875B, exp. date 03/2022; 31326915B, exp. date 03/2022; 31326916B, 31326917B, exp. date 04/2022; 31329079B, exp. date 04/2023; 31329085B, exp. date 05/2023
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
- 62,358 vials
- Distribution pattern
- Product was distributed Nationwide, including Puerto Rico.
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-16
- Posted by FDA
- 2021-08-25
- Terminated
- 2024-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0735-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.