Par Pharmaceutical, Inc. recalls Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: P
Recalled September 19, 2018 · FDA recall D-1185-2018 · Par Pharmaceutical
Hazard
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels. · FDA Class III
Units
16,207 (bottles of 30 tablets)
Sold at
United States nationwide
Description
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
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
Manufacturer(s)
Par Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →