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
Reported: November 7, 2018 Initiated: October 22, 2018 #D-0128-2019
Product Description
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
Reason for Recall
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Details
- Recalling Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Units Affected
- 1,380 100-count bottles
- Distribution
- Distributed nationwide in the USA and Puerto Rico
- Location
- Ridgefield, CT
Frequently Asked Questions
What product 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. Recalled by Boehringer Ingelheim Pharmaceuticals, Inc.. Units affected: 1,380 100-count bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 7, 2018. Severity: Moderate. Recall number: D-0128-2019.
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