FDA-Drug2019-03-20Class III
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
Boehringer Ingelheim Pharmaceuticals, Inc.
Hazard
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Sold states
Nationwide in the USA
Affected count
112 folding cartons
Manufactured in
900 Ridgebury Rd, N/A, Ridgefield, CT, United States
Products
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0991-2019Don't want to check this manually?
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