Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
USPrimidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Recalling Firm: Amerisource Health Services LLC
Grund für den Rückruf / Gefahr
TranslatedCross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Produktbeschreibung & Identifikation
TranslatedPrimidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Betroffene Produkte
TranslatedPrimidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Additional Source Details
| Field | Value |
|---|---|
| City | Columbus |
| State | OH |
| 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 | 23950268-33a3-8f1e-e063-6394a90a736a |
| Openfda › Brand name | PRIMIDONE |
| Openfda › Spl set id | a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11 |
| Openfda › Package ndc › 1 | 68084-203-11 |
| Openfda › Package ndc › 2 | 68084-203-01 |
| Openfda › Package ndc › 3 | 68084-202-11 |
| Openfda › Package ndc › 4 | 68084-202-01 |
| Openfda › Product ndc › 1 | 68084-202 |
| Openfda › Product ndc › 2 | 68084-203 |
| 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 | American Health Packaging |
| Openfda › Application number | ANDA084903 |
| Openfda › Original packager product ndc › 1 | 0527-1231 |
| Openfda › Original packager product ndc › 2 | 0527-1301 |
| Event id | 98884 |
| Address 1 | 2550 John Glenn Ave Ste A |
| Code info | Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027 |
| Postal code | 43217-1188 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | 225,000 tablets |
| Reason for recall | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260501 |
| Initial firm notification | Letter |
| Center classification date | 20260518 |
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 (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American...?
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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Übersicht
- Rückrufendes UnternehmenAmerisource Health Services LLC
- StatusOngoing
- RisikostufeClass III
- DistributionUSA Nationwide
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🚨 SAFETY ALERT: Amerisource Health Services LLC - Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11 Check if your household is affected: https://therecallfile.com/de/recalls/primidone-tablets-usp-50-mg-100-tablets-10-x-10-unit-dose-blister-per/FDA-D-0537-2026
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