Home / Recalls / Boehringer Ingelheim Pharmaceuticals, Inc. / D-0242-2018

D-0242-2018 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
February 7, 2018
Initiation Date
December 14, 2017
Termination Date
October 17, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45,008 units/90 capsules each unit

Product Description

SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47

Reason for Recall

Failed Stability Specifications

Distribution Pattern

Distributed nationwide

Code Information

Lot # 606478; Exp. 03/18

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  • D-0053-2021 Class II — Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx on (October 5, 2020)
  • D-0052-2021 Class II — Catapres (clonidine hydrochloride, USP) 0.2 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-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-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)