Drug 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
D-0051-2021
Product summary
- Event
- Event 86527
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,270 bottles/100 tablets each
- Official record key
drug-enforcement:D-0051-2021
Official wording
Reason: An extraneous peak was observed for dissolution testing.
Code information: Lot # 761544, 859015, EXP Jan 2021, 861346, 956626, EXP Jan 2022
Distribution pattern: Distributed Nationwide in the USA and Puerto Rico
Derived failure modes
-
Unknown
An extraneous peak was observed for dissolution testing.