FDA recall D-1185-2018

Product

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

Reason for recall

Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.

Distribution

United States nationwide

Key facts

Status

Terminated

Initiation date

2018-09-06

Report date

2018-09-19

Termination date

2019-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chestnut Ridge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1185-2018