Drug Enforcement D-0112-2025

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

Status

Terminated

Classification

Class II

Report Date

December 11, 2024

Termination Date

June 27, 2025

Product Information

Product description
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Product quantity
1608 bottles
Reason for recall
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Lannett Company Inc.
Address
1101 C Ave W

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

Codes & Dates

Recall number
D-0112-2025
Event ID
95630
Recall initiation date
October 25, 2024
Center classification date
December 5, 2024
Code info
Lot: 23274856A, Exp 04/30/2025
More code info
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