Sandoz pramipexole dihydrochloride 0.125mg tablets: impurities

[notyard]

FDA recall:

PRODUCT
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, NDC 0781-5248-92, UPC 3 0781-5248-92 5. Recall # D-1367-2012
CODE
Lot #: BJ3186, BJ3142, Exp 12/12.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Inc., Broomfield, CO, by letter dated March 22, 2012.
Manufacturer: Sandoz Private Limited, Navi Mumbai, Maharashtra, India. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
7,545 bottles
DISTRIBUTION
Nationwide and PR