FDA recall D-0146-2020

Product

Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839

Reason for recall

Crystallization: Presence of particulate matter identified as API crystallization

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2019-10-09

Report date

2019-10-23

Termination date

2020-12-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2020