D-171-2013 Class II Terminated
FDA drug recall D-171-2013 was initiated by Amedra Pharmaceuticals LLC on December 4, 2012 and is designated Class II. Reason for recall: Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. The recall status is terminated (terminated March 21, 2014). Affected quantity: 1,176 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 6, 2013
- Initiation Date
- December 4, 2012
- Termination Date
- March 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,176 bottles
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 64720-327-09
Reason for Recall
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot 238316, exp 01/31/2014