Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…
Reason Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Class I — High risk. Reasonable probability of serious harm or death.
Labeling: Label Mix-up
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
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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