Pramipexole Dihydrochloride Tablets recall: Impurity Out of Spec
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,
Why was Pramipexole Dihydrochloride Tablets recalled?
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12
- 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,
- Recalling firm
- Sandoz Incorporated
- Quantity
- 43,060 x 90 count bottles
- Distribution
- Nationwide
- Recall date
- September 26, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)