Drug 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
D-1678-2012
Product summary
- Event
- Event 63160
- Status
- Terminated
- Classification
- Class III
- Quantity
- 41,761bottles.
- Official record key
drug-enforcement:D-1678-2012
Official wording
Reason: Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Code information: Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification