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
What was recalled
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
- Recalling firm
- Actavis Elizabeth LLC
- NDC code
- 45963-305-09
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0395-2015
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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