Recalls / Class II
Class IID-0052-2021
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
- Affected lot / code info
- Lot # 861135, C34139, EXP Nov 2021
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
- N/A
- 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-0052-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.