Drug recall
Methimazole, USP; 10 mg tablets; 100 or 1000 tablets per bottle (some bulk); Rx; Caraco Pharmaceutical…
FDA recall event 53459 · Class II · Caraco Pharmaceutical Laboratories, Ltd.
Key facts
| Event ID | 53459 |
|---|---|
| Recall numbers | D-758-2010, D-759-2010 |
| Recalling firm | Caraco Pharmaceutical Laboratories, Ltd. |
| Product type | Drugs |
| Products | Methimazole, USP; 10 mg tablets; 100 or 1000 tablets per bottle (some bulk); Rx; Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI; NDC 57664-459-88 (100 count), NDC 57664-459-18 (1000 count)., Methimazole, USP; 5 mg tablets; 100 or 1000 tablets per bottle (some bulk); Rx; Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI; NDC 57664-458-88 (100 count), NDC 57664-458-18 (1000 count). |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation products. The product failed 18 month stability testing. |
| Initiation date | Aug 18, 2009 |
| Termination date | Nov 19, 2010 |
| City | Detroit |
| State | MI |
| Country | United States |
| FEI number | 1833173 |
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