Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10
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:
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.