DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SU...
FDA Recall #D-0566-2016 — Class II — November 12, 2015
Product Description
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Recalling Firm
Teva Pharmaceuticals USA — North Wales, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9,717 bottles
Distribution
Nationwide
Code Information
Lot #: 34015516A, Exp 05/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated