D-0053-2021 Class II Terminated
FDA drug recall D-0053-2021 was initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on Oct 5, 2020 and is designated Class II. Reason for recall: An extraneous peak was observed for dissolution testing. The recall status is terminated (terminated Sep 29, 2021).
Recall details
- Product Type
- Drugs
- Report Date
- Nov 4, 2020
- Initiation Date
- Oct 5, 2020
- Termination Date
- Sep 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product description
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
Reason for recall
An extraneous peak was observed for dissolution testing.
Distribution pattern
Distributed Nationwide in the USA and Puerto Rico
Code information
Lot # 954953, EXP Jan 2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0053-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026