FDA DrugsClass III
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett...
Published: May 27, 2026Recall ID: D-0533-2026Category: 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, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Seymour |
| State | IN |
| Openfda › Nui › 1 | N0000175753 |
| Openfda › Nui › 2 | N0000008486 |
| Openfda › Upc | 0305871231011 |
| Openfda › Unii | 13AFD7670Q |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 96304 |
| Openfda › Rxcui › 2 | 198150 |
| Openfda › Spl id | 99bd0a67-2742-43dd-9ddc-430b9141c3b1 |
| Openfda › Brand name | PRIMIDONE |
| Openfda › Spl set id | a1a817f7-c190-4825-94eb-442f477187e3 |
| Openfda › Package ndc › 1 | 0527-1301-01 |
| Openfda › Package ndc › 2 | 0527-1301-05 |
| Openfda › Package ndc › 3 | 0527-1301-10 |
| Openfda › Package ndc › 4 | 0527-1231-01 |
| Openfda › Package ndc › 5 | 0527-1231-05 |
| Openfda › Package ndc › 6 | 0527-1231-10 |
| Openfda › Product ndc › 1 | 0527-1231 |
| Openfda › Product ndc › 2 | 0527-1301 |
| 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 | Lannett Company, Inc. |
| Openfda › Application number | ANDA084903 |
| Openfda › Is original packager | true |
| Event id | 98791 |
| Address 1 | 1101 C Ave W |
| Code info | Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028. |
| Postal code | 47274-3342 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | 44865 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 | 20260424 |
| Initial firm notification | Letter |
| Center classification date | 20260518 |
Overview
- Recalling FirmLannett Company Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionUSA Nationwide