Drug recall
Mysoline (primidone) Tablets, 50 mg tablets, 500 count bottles. Rx Only, Manufactured by: Yamanouchi Pharma…
FDA recall event 28237 · Class III · Xcel Pharmaceuticals Inc
Key facts
| Event ID | 28237 |
|---|---|
| Recall numbers | D-112-4 |
| Recalling firm | Xcel Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Mysoline (primidone) Tablets, 50 mg tablets, 500 count bottles. Rx Only, Manufactured by: Yamanouchi Pharma Technologies, Inc., Norman, Ok, Distributed by: Xcel Pharmaceuticals, Inc., San Diego, CA… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Tablet hardness failure |
| Initiation date | Jan 29, 2004 |
| City | San Diego |
| Country | United States |
| FEI number | 3003413267 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports