Information
American Regent Recalls Levocarnitine Injection
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0494-2026Drug / Pharmaceutical
American Regent Recalls Levocarnitine Injection
American Regent, Inc. · Class III — Regulatory
Product Description
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Reason for Recall
Labeling: Missing Label
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database