Drug Enforcement D-0590-2024

Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

Status

Ongoing

Classification

Class II

Report Date

July 17, 2024

Termination Date

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Product Information

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.
Product quantity
2,484 cartons
Reason for recall
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Amerisource Health Services LLC
Address
2550 John Glenn Ave Ste A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0590-2024
Event ID
94891
Recall initiation date
June 24, 2024
Center classification date
July 8, 2024
Code info
Lot 1017343, Exp. 12/31/2025
More code info
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