Drug product
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
D-0747-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,046 vials
- Official record key
drug-enforcement:D-0747-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 313282585B, exp. date 11/2022
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility