Drug product
Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01
D-0053-2021
Product summary
- Event
- Event 86527
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0053-2021
Official wording
Reason: An extraneous peak was observed for dissolution testing.
Code information: Lot # 954953, 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.