FDA recall D-128-2013

Teva Pharmaceuticals USA, Inc. · Class III · drug

Product

CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88

Reason for recall

Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2012-04-24
Report date
2013-01-23
Termination date
2013-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-128-2013