Drug recall
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by…
FDA recall event 63160 · Class III · Sandoz Incorporated
Key facts
| Event ID | 63160 |
|---|---|
| Recall numbers | D-1677-2012, D-1678-2012 |
| Recalling firm | Sandoz Incorporated |
| Product type | Drugs |
| Products | Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92, Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92, |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. |
| Initiation date | Sep 12, 2012 |
| Report date | Sep 26, 2012 |
| Termination date | Apr 10, 2013 |
| City | Broomfield |
| State | CO |
| Country | United States |
| FEI number | 1717759 |
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 · Source date: