• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 63926
Product Type Drugs
Status Ongoing
Recalling Firm Amedra Pharmaceuticals LLC
City Horsham
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide and Puerto Rico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot 220843, exp 11/30/2013 Class II Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. 10,968 bottles D-173-2013
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09 Lot 220839, exp 11/30/2013 Class II Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. 12,948 bottles D-172-2013
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09 Lot 238316, exp 01/31/2014 Class II Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. 1,176 bottles D-171-2013
-
-