Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
USPrimidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Recalling Firm: Amneal Pharmaceuticals, LLC
Motif du rappel / Danger
TranslatedCross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Description du produit & Identification
TranslatedPrimidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Produits concernés
TranslatedPrimidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Additional Source Details
| Field | Value |
|---|---|
| City | Bridgewater |
| State | NJ |
| Openfda › Nui › 1 | N0000175753 |
| Openfda › Nui › 2 | N0000008486 |
| Openfda › Unii | 13AFD7670Q |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 96304 |
| Openfda › Rxcui › 2 | 198150 |
| Openfda › Spl id | 574c0bff-04c5-41f0-8d10-315a824d8efd |
| Openfda › Brand name | PRIMIDONE |
| Openfda › Spl set id | 3cdc361a-5558-4341-ad40-f8bc29b4f1ce |
| Openfda › Package ndc › 1 | 53746-544-01 |
| Openfda › Package ndc › 2 | 53746-544-10 |
| Openfda › Package ndc › 3 | 53746-544-05 |
| Openfda › Package ndc › 4 | 53746-545-01 |
| Openfda › Package ndc › 5 | 53746-545-10 |
| Openfda › Package ndc › 6 | 53746-545-05 |
| Openfda › Product ndc › 1 | 53746-544 |
| Openfda › Product ndc › 2 | 53746-545 |
| Openfda › Generic name | PRIMIDONE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Openfda › Substance name | PRIMIDONE |
| Openfda › Pharm class epc | Anti-epileptic Agent [EPC] |
| Openfda › Manufacturer name | Amneal Pharmaceuticals of New York LLC |
| Openfda › Application number | ANDA040866 |
| Openfda › Is original packager | true |
| Event id | 99146 |
| Address 1 | 400 Crossing Blvd Fl 3 |
| Address 2 | N/A |
| Code info | Lot AM251676, EXP 11/31/2028 |
| Postal code | 08807-2863 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | 27,936 100-count bottles |
| Reason for recall | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260603 |
| Initial firm notification | Letter |
| Center classification date | 20260610 |
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 Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Or...?
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 responsableAmneal Pharmaceuticals, LLC
- StatusOngoing
- Niveau de risqueClass III
- DistributionNationwide within the USA.
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🚨 SAFETY ALERT: Amneal Pharmaceuticals, LLC - Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 Check if your household is affected: https://therecallfile.com/fr/recalls/primidone-tablets-usp-50-mg-100-tablets-per-bottle-rx-only-manufacture/FDA-D-0585-2026
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