Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95
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.
Reason Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Reason Failed Impurities/Degradation Specifications:
Reason Failed Impurities/Degradation Specifications:
Reason Failed Impurities/Degradation Specifications:
Reason Failed Impurities/Degradation Specifications:
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