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Recall Observatory FDA recall evidence

Drug product

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

D-0052-2021

October 05, 2020

Class II

Product summary

Firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Event
Event 86527
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0052-2021

Official wording

Reason: An extraneous peak was observed for dissolution testing.

Code information: Lot # 861135, C34139, EXP Nov 2021

Distribution pattern: Distributed Nationwide in the USA and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An extraneous peak was observed for dissolution testing.