Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceut…
- Recall date
- October 22, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0128-2019
- FDA classification
- Class II
- Brand / firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Sold / distributed
- Distributed nationwide in the USA and Puerto Rico
Why it was recalled
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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