Reported May 6, 2026 · Ongoing
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American…
American Regent, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Regent, Inc. · 6610 New Albany Rd E · New Albany, OH · 43054-8730
Is this the product you have?
- 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
- NDC0517-1045-01
- Lot codes and dates
Lot 24159N0C0Exp. June 302026 Lot 25193N0C0Exp. July 312027
- Amount recalled
- 74,040 Single Dose Vials
Where it was sold
- Nationwide
Why it was recalled
Labeling: Missing Label
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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