Teva Pharmaceuticals USA: Drug Recall
Recall #D-0374-2021 · 04/26/2021
Class II: Risk
Recall Details
- Recall Number
- D-0374-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Teva Pharmaceuticals USA
- Status
- Terminated
- Date Initiated
- 04/26/2021
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192,277 cartons/1 single dose vial per carton
Reason for Recall
Lack of Assurance of Sterility
Product Description
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)
Distribution Pattern
Product was distributed nationwide.
Other Recalls by Teva Pharmaceuticals USA
- Class II: Risk 01/18/2022
- Class II: Risk 01/10/2022
- Class III: Low Risk 01/07/2022
- Class III: Low Risk 01/07/2022
- Class II: Risk 12/31/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.