Recalls / Class II
Class IID-0128-2019
Product
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
- Affected lot / code info
- Lot: 757739, EXP 9/2020
Why it was recalled
Failed Dissolution Specifications: OOS resultsduring routine stability 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
- 1,380 100-count bottles
- Distribution pattern
- Distributed nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-10-22
- FDA classified
- 2018-11-01
- Posted by FDA
- 2018-11-07
- Terminated
- 2023-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0128-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.