FDA recall D-171-2013

Amedra Pharmaceuticals LLC · Class II · drug

Product

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

Nationwide and Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2012-12-04
Report date: 2013-03-06
Termination date: 2014-03-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-171-2013