Class III
Terminated
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,
- Company
- Sandoz Incorporated
- Recall Initiated
- September 12, 2012
- Posted
- September 26, 2012
- Recall Number
- D-1677-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 43,060 x 90 count bottles
- Firm Location
- Broomfield, CO, United States
Reason for Recall
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Distribution
Nationwide
Lot / Code Info
Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12
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