Recalls / Class III
Class IIID-1678-2012
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
- Affected lot / code info
- Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
Why it was recalled
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 41,761bottles.
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-12
- FDA classified
- 2012-09-19
- Posted by FDA
- 2012-09-26
- Terminated
- 2013-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1678-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.