FDA Drug recall D-1678-2012
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sand…
- FDA Drug
- Class III
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class III recall of Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sand… by Sandoz, citing impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1678-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-09-12 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
Product
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
Reason
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Identifiers
| code_info | Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1678-2012%22
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