Drug product
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.
D-0276-2021
Product summary
- Event
- Event 87298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 248,565 vials
- Official record key
drug-enforcement:D-0276-2021
Official wording
Reason: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Code information: Lot # 31326364B, exp. date 01/2022 31327120B, exp. date 05/2022 31327963B, exp. date 10/2022
Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility