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
Reported: September 26, 2012 Initiated: September 12, 2012 #D-1678-2012
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
Reason for Recall
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Details
- Recalling Firm
- Sandoz Incorporated
- Units Affected
- 41,761bottles.
- Distribution
- Nationwide
- Location
- Broomfield, CO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Incorporated. Units affected: 41,761bottles..
Why was this product recalled? ▼
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 26, 2012. Severity: Low. Recall number: D-1678-2012.
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