Sandoz pramipexole dihydrochloride 0.125mg tablets: impurities
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
Lot #: BJ3186, BJ3142, Exp 12/12.
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.
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
Nationwide and PR
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