Ingenus Pharmaceuticals Llc recalls Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Phar…

Recall date

October 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0146-2020

FDA classification

Class II

Brand / firm

Ingenus Pharmaceuticals Llc

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Crystallization: Presence of particulate matter identified as API crystallization

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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