Drug product
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.)
D-0374-2021
Product summary
- Event
- Event 87875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192,277 cartons/1 single dose vial per carton
- Official record key
drug-enforcement:D-0374-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: NDC 0703-5145-01: Lot # 31325332B, exp. date 08/2021, Lot # 31325756B, exp. date 09/2021 AND NDC 0703-5145-91: Lot # 31325685B, exp. date 09/2021
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility