Class II · Moderate risk Ongoing
Dextroamphetamine Saccharate
Reason Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Dextroamphetamine Sulfate Extended Release Capsules
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 64720-328-09
- Recalling firm
- Amedra Pharmaceuticals LLC
- NDC code
- 64720-328-09
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-172-2013
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.
Other Dextroamphetamine recalls
See all
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
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