Drug product
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
D-0737-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 434,229 vials
- Official record key
drug-enforcement:D-0737-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 31325852B, 31325985B, exp. date 10/2021; 31326349B, exp. date 01/2022; 31326873B, exp. date 03/2022; 31326995B, exp. date 05/2022 31327158B, exp. date 06/2022; 31328946B, 31329180B, exp. date 05/2023.
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility