Drug product
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
D-0746-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 476,275 vials
- Official record key
drug-enforcement:D-0746-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 31325596B, exp. date 08/2021; 31328129B, exp. date 11/2022; 31328356B, exp. date 01/2023; 31329297B, exp. date 06/2023; 31329569B, 31329821B, exp. date 08/2023
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility