CARVEDILOL Recall D-0263-2022
Description: Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
CARVEDILOL Recall D-0263-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0263-2022 |
| Event ID | 89045 |
| Brand | CARVEDILOL |
| Generic Name | CARVEDILOL |
| Manufacturer | CARVEDILOL |
| Original Package? | 1 |
| Active Substance | CARVEDILOL |
| Drug Route | ORAL |
| Distribution | Nationwide in the US |
| Quantity | 7296 containers |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class III |
| Drug Code Info | 20211201 |
| Product NDC | 65862-142 65862-143 65862-144 |
| Product NUI | N0000000099 N0000009923 N0000009924 |
| Pharma Class (EPC) | alpha-Adrenergic Blocker [EPC] |
| Recall Initiation Date | 20211115 |
| Report Date | 20211201 |
| Classification Date | 20211201 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Aurobindo Pharma USA Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0K47UL67F2 |
| Drug Application Number | ANDA078332 |
| Structured Product Labeling (SPL ID) | e1a6c057-619f-4a31-ad0a-c76f4235da6a |
| Structured Product Labeling (SPL Set ID) | 7cc14b86-0833-4c3c-91f3-7963d7052fd5 |
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