FDA-Drug2012-09-26Class III
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
Sandoz Incorporated
Hazard
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Sold states
Nationwide
Affected count
41,761bottles.
Manufactured in
2555 W Midway Blvd, Broomfield, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1678-2012Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief