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
USLevocarnitine 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
Recalling Firm: American Regent, Inc.
Motif du rappel / Danger
TranslatedLabeling: Missing Label
Description du produit & Identification
TranslatedLevocarnitine 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
Produits concernés
TranslatedLevocarnitine 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 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Reg...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Aperçu
- Entreprise responsableAmerican Regent, Inc.
- StatusOngoing
- Niveau de risqueClass III
- DistributionU.S. Nationwide
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🚨 SAFETY ALERT: 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 11967. NDC: 0517-1045-01 Check if your household is affected: https://therecallfile.com/fr/recalls/levocarnitine-injection-usp-1-g-5-ml-200-mg-ml-5-ml-single-dose-vial-f/FDA-D-0494-2026
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