US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 4, 2012 (14 years ago)

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

What was recalled

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09

Recalling firm
Amedra Pharmaceuticals LLC
NDC code
64720-327-09
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-171-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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