Drug 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
D-0128-2019
Product summary
- Event
- Event 81340
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,380 100-count bottles
- Official record key
drug-enforcement:D-0128-2019
Official wording
Reason: Failed Dissolution Specifications: OOS resultsduring routine stability testing
Code information: Lot: 757739, EXP 9/2020
Distribution pattern: Distributed nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications