American Regent, Inc.: 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
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- American Regent, Inc.
- Product
- 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 / hazard
- Labeling: Missing Label
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide
- Recall initiated
- 2026-04-16
- Code info
- Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
- Product quantity
- 74,040 Single Dose Vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- New Albany
- State
- OH
- Country
- United States
- Event id
- 98787
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