FDA-Drug2024-12-11Class II

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

Lannett Company Inc.
Hazard

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

Sold states
Nationwide in the USA
Affected count
1608 bottles
Manufactured in
1101 C Ave W, Seymour, IN, United States
Products
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2025

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