FDAFDA · Food and drugs·Recall number D-1678-2012
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
Published September 26, 2012 · Recall initiated: September 12, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz Incorporated
- Distributor
- Nationwide
- Lot
- Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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