D-0737-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 25, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 434,229 vials
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed Nationwide, including Puerto Rico.
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.