Home / Recalls / Boehringer Ingelheim Pharmaceuticals, Inc. / D-0128-2019

D-0128-2019 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
November 7, 2018
Initiation Date
October 22, 2018
Termination Date
April 3, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,380 100-count bottles

Product Description

Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01

Reason for Recall

Failed Dissolution Specifications: OOS resultsduring routine stability testing

Distribution Pattern

Distributed nationwide in the USA and Puerto Rico

Code Information

Lot: 757739, EXP 9/2020

Other recalls by Boehringer Ingelheim Pharmaceuticals, Inc.

  • D-0468-2023 Class II — JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153- (March 9, 2023)
  • D-0600-2021 Class II — Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx on (May 4, 2021)
  • 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-0991-2019 Class III — Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets (March 7, 2019)
  • 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)