Home / Recalls / Boehringer Ingelheim Pharmaceuticals, Inc. / D-0991-2019

D-0991-2019 Class III Terminated

Recalled by Boehringer Ingelheim Pharmaceuticals, Inc. — Ridgefield, CT

Recall Details

Product Type
Drugs
Report Date
March 20, 2019
Initiation Date
March 7, 2019
Termination Date
September 11, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112 folding cartons

Product Description

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.

Reason for Recall

Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # AA3280A, Exp SEP 2019

Other recalls by Boehringer Ingelheim Pharmaceuticals, Inc.

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  • D-0052-2021 Class II — Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx on (October 5, 2020)
  • D-0053-2021 Class II — Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx on (October 5, 2020)
  • D-0051-2021 Class II — Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx on (October 5, 2020)
  • D-0128-2019 Class II — Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Di (October 22, 2018)
  • D-1217-2018 Class II — Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx o (September 4, 2018)
  • D-0242-2018 Class II — SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 ca (December 14, 2017)
  • D-0007-2018 Class III — Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by (September 22, 2017)
  • D-0113-2017 Class II — Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. (October 6, 2016)