FDA DrugsClass III
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i...
Published: May 6, 2026Recall ID: D-0494-2026Category: drugsCountry: US
Reason for Recall / Hazard
Labeling: Missing Label
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | New Albany |
| State | OH |
| Openfda › Nui › 1 | M0003493 |
| Openfda › Nui › 2 | N0000175903 |
| Openfda › Unii | 0G389FZZ9M |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 1791371 |
| Openfda › Rxcui › 2 | 2673428 |
| Openfda › Spl id | 114eaeda-8965-4c92-a3ff-15021b305464 |
| Openfda › Brand name | LEVOCARNITINE |
| Openfda › Spl set id | cc4da2c3-f939-444d-9b5b-a57b6051c190 |
| Openfda › Package ndc › 1 | 0517-1045-01 |
| Openfda › Package ndc › 2 | 0517-1045-05 |
| Openfda › Package ndc › 3 | 0517-1075-01 |
| Openfda › Product ndc › 1 | 0517-1045 |
| Openfda › Product ndc › 2 | 0517-1075 |
| Openfda › Generic name | LEVOCARNITINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Carnitine [CS] |
| Openfda › Substance name | LEVOCARNITINE |
| Openfda › Pharm class epc | Carnitine Analog [EPC] |
| Openfda › Manufacturer name | American Regent, Inc. |
| Openfda › Application number | ANDA075861 |
| Openfda › Is original packager | true |
| Event id | 98787 |
| Address 1 | 6610 New Albany Rd E |
| Code info | Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027 |
| Postal code | 43054-8730 |
| Report date | 20260506 |
| Product type | Drugs |
| Product quantity | 74,040 Single Dose Vials |
| Reason for recall | Labeling: Missing Label |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260416 |
| Initial firm notification | Letter |
| Center classification date | 20260428 |
Overview
- Recalling FirmAmerican Regent, Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionU.S. Nationwide