BUPROPION HYDROCHLORIDE Recall D-0590-2024
Description: buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
BUPROPION HYDROCHLORIDE Recall D-0590-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0590-2024 |
| Event ID | 94891 |
| Brand | BUPROPION HYDROCHLORIDE |
| Generic Name | BUPROPION HYDROCHLORIDE |
| Manufacturer | BUPROPION HYDROCHLORIDE |
| Active Substance | BUPROPION HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 2,484 cartons |
| Recall Reason | Failed Dissolution Specifications; the product is dissolving faster than the specified limits. |
| Drug Classification | Class II |
| Drug Code Info | 20240717 |
| Product NDC | 60687-782 60687-793 |
| Recall Initiation Date | 20240624 |
| Report Date | 20240717 |
| Classification Date | 20240708 |
| Address | 2550 John Glenn Ave Ste AN/A Columbus, OH 43217-1188 United States |
| Recalling Firm | Amerisource Health Services LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | ZG7E5POY8O |
| Drug Application Number | ANDA090693 |
| Structured Product Labeling (SPL ID) | 0fc93daf-0dfa-f8fa-e063-6394a90a95cd |
| Structured Product Labeling (SPL Set ID) | 8dab6d17-bf41-4a28-90db-b66959c0e143 |
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