Why it was recalled
Lack of Assurance of Sterility
Product description
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed Nationwide, including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0735-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- 62,358 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0735-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88442
- Address
- 400 Interpace Pkwy
- Code information
- 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
- Postal code
- 07054-1120
- Report date
- Aug 25, 2021
- Product type
- Drugs
- Recall number
- D-0735-2021
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 62,358 vials
- Termination date
- Jun 4, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
- Distribution pattern
- Product was distributed Nationwide, including Puerto Rico.
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2021