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.
Reported: July 17, 2024 Initiated: June 24, 2024 #D-0590-2024
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.
Details
- Recalling Firm
- Amerisource Health Services LLC
- Units Affected
- 2,484 cartons
- Distribution
- Nationwide in the USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Amerisource Health Services LLC. Units affected: 2,484 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2024. Severity: Moderate. Recall number: D-0590-2024.
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