Lannett Company, Inc. recalls 8,544 bottles of Lisdexamfetamine Dimesylate 40 mg capsules distributed nationwide. A labeling mix-up may have placed 30 mg and 40 mg strengths in mislabeled bottles. Healthcare providers and patients should stop use and contact the company for guidance.
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Consumers and healthcare providers should stop using this product immediately. Contact Lannett Company Inc. or your healthcare provider for guidance. Notification method: Letter
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Lisdexamfetamine Dimesylate is a prescription stimulant used to treat ADHD and binge-eating disorder.
Label mix-up can lead to dosing errors if patients use the mislabeled 40 mg bottle thinking it contains 40 mg when it may actually be 30 mg.
This recall is not described as a broader pattern for labeling errors in this product category.
Could cause under-dosing or misdosing in patients relying on the label for dosage guidance.
NDC 0527-4664-37, Lot 25280726A, Exp. 03/2027 on packaging and bottle.
Notification by letter; replacement or guidance may take weeks.
Keep recall letter, packaging, and any correspondence with healthcare providers.
Brand: Lisdexamfetamine Dimesylate. Product: Capsules, 40 mg, 100-count bottles. Distribution: Nationwide in the USA. Distributor: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-4664-37. Lot: 25280726A. Expiration: 03/2027. Quantity: 8544 bottles.
No specific injuries or adverse events are reported in the recall notice.
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