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 Pharm
Recalled October 23, 2019 · FDA recall D-0146-2020 · Ingenus Pharmaceuticals
Hazard
Crystallization: Presence of particulate matter identified as API crystallization · FDA Class II
Units
16485 vials
Sold at
U.S.A. Nationwide
Description
Crystallization: Presence of particulate matter identified as API crystallization
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
Manufacturer(s)
Ingenus Pharmaceuticals Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →