Why it was recalled
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1678-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 12, 2012
- FDA report date
- Sep 26, 2012
- Quantity
- 41,761bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-1678-2012, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 63160
- Address
- 2555 W Midway Blvd
- Code information
- Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
- Postal code
- 80020-1632
- Report date
- Sep 26, 2012
- Product type
- Drugs
- Recall number
- D-1678-2012
- Classification
- Class III
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 41,761bottles.
- Termination date
- Apr 10, 2013
- Reason for recall
- Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 12, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 19, 2012