FDA recall D-0746-2021

Teva Pharmaceuticals USA · Class II · 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

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed Nationwide, including Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2021-07-29
Report date: 2021-08-25
Termination date: 2024-06-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0746-2021