Drug recall
Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mg. The product is packaged as 250 tablets per bag…
FDA recall event 34555 · Class II · Heartland Repack Services LLC
Key facts
| Event ID | 34555 |
|---|---|
| Recall numbers | D-175-6, D-176-6, D-177-6 |
| Recalling firm | Heartland Repack Services LLC |
| Product type | Drugs |
| Products | Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mg. The product is packaged as 250 tablets per bag, NDC #61392-647-25, Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mg. The product is packaged as 30 tablets per box, NDC #61392-647-30., Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mg. The product is packaged as 60 tablets per box, NDC #61392-647-60. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The incorrect stability test method was used to assure that the product meets its specifications throughout its shelf life |
| Initiation date | Feb 8, 2006 |
| Termination date | Feb 27, 2012 |
| City | Toledo |
| State | OH |
| Country | United States |
| FEI number | 1000305984 |
At a glance
- 1–9 Products in this recall
- 1–9 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