Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by ...
FDA Recall #D-173-2013 — Class II — December 4, 2012
Product Description
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
Reason for Recall
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Recalling Firm
Amedra Pharmaceuticals LLC — Horsham, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
10,968 bottles
Distribution
Nationwide and Puerto Rico.
Code Information
Lot 220843, exp 11/30/2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated