D-0590-2024 Class II Ongoing
FDA drug recall D-0590-2024 was initiated by Amerisource Health Services LLC on Jun 24, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications; the product is dissolving faster than the specified limits. The recall status is ongoing. Affected quantity: 2,484 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 17, 2024
- Initiation Date
- Jun 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,484 cartons
Product 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.
Reason for Recall
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 1017343, Exp. 12/31/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0590-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026