Recalls / Class II
Class IID-0051-2021
Product
Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
- Affected lot / code info
- Lot # 761544, 859015, EXP Jan 2021, 861346, 956626, EXP Jan 2022
Why it was recalled
An extraneous peak was observed for dissolution testing.
Recalling firm
- Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 900 Ridgebury Rd, N/A, Ridgefield, Connecticut 06877-1058
Distribution
- Quantity
- 13,270 bottles/100 tablets each
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2020-10-05
- FDA classified
- 2020-10-26
- Posted by FDA
- 2020-11-04
- Terminated
- 2021-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0051-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.