Recall Enforment Report D-0052-2021
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Boehringer Ingelheim Pharmaceuticals, Inc., originally initiated on 10-05-2020 for the product Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01 The product was recalled due to an extraneous peak was observed for dissolution testing.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0052-2021 | 10-05-2020 | 11-04-2020 | Class II | N/A | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01 | An extraneous peak was observed for dissolution testing. | Terminated |
| D-0051-2021 | 10-05-2020 | 11-04-2020 | Class II | 13,270 bottles/100 tablets each | 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 | An extraneous peak was observed for dissolution testing. | Terminated |
| D-0053-2021 | 10-05-2020 | 11-04-2020 | Class II | N/A | 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 | An extraneous peak was observed for dissolution testing. | Terminated |
