FDA DrugsClass III
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carto...
Published: May 27, 2026Recall ID: D-0537-2026Category: drugsCountry: US
Reason for Recall / Hazard
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product Description & Identification
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
Affected Products
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
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 |
Overview
- Recalling FirmAmerisource Health Services LLC
- StatusOngoing
- Risk LevelClass III
- DistributionUSA Nationwide