Drug product
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,
D-1677-2012
Product summary
- Event
- Event 63160
- Status
- Terminated
- Classification
- Class III
- Quantity
- 43,060 x 90 count bottles
- Official record key
drug-enforcement:D-1677-2012
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: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification