FDA-Drug2019-10-23Class II

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

Ingenus Pharmaceuticals Llc
Hazard

Crystallization: Presence of particulate matter identified as API crystallization

Sold states
U.S.A. Nationwide
Affected count
16485 vials
Manufactured in
4190 Millenia Blvd, N/A, Orlando, FL, United States
Products
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

Official notice

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

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