FDA-Drug2013-03-06Class II
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
Amedra Pharmaceuticals LLC
Hazard
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Sold states
Nationwide and Puerto Rico.
Affected count
12,948 bottles
Manufactured in
2 Walnut Grove Dr, Suite 190, Horsham, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-172-2013Don't want to check this manually?
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