FDA DrugsClass III
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannet...
Published: May 27, 2026Recall ID: D-0534-2026Category: 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, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Affected Products
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Additional Source Details
| Field | Value |
|---|---|
| City | Camarillo |
| State | CA |
| 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 | 29f49f7f-d100-e0e1-e063-6394a90ac981 |
| Openfda › Brand name | PRIMIDONE |
| Openfda › Spl set id | e4e493bd-94d7-7e5a-e053-2995a90a2706 |
| Openfda › Package ndc › 1 | 51407-637-01 |
| Openfda › Package ndc › 2 | 51407-637-05 |
| Openfda › Package ndc › 3 | 51407-638-01 |
| Openfda › Product ndc › 1 | 51407-637 |
| Openfda › Product ndc › 2 | 51407-638 |
| 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 | Golden State Medical Supply, Inc |
| Openfda › Application number | ANDA084903 |
| Openfda › Original packager product ndc › 1 | 0527-1301 |
| Openfda › Original packager product ndc › 2 | 0527-1231 |
| Event id | 98856 |
| Address 1 | 5187 Camino Ruiz |
| Code info | Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028 |
| Postal code | 93012-8601 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | 8,526 bottles |
| Reason for recall | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Letter |
| Center classification date | 20260518 |
Overview
- Recalling FirmGolden State Medical Supply Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionUSA Nationwide