FDA recall D-1678-2012

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-09-12

Report date

2012-09-26

Termination date

2013-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1678-2012