FDA-Drug2018-09-19Class III
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
Par Pharmaceutical, Inc.
Hazard
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Sold states
United States nationwide
Affected count
16,207 (bottles of 30 tablets)
Manufactured in
1 Ram Ridge Rd, N/A, Chestnut Ridge, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1185-2018Don't want to check this manually?
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