FDA-Drug2014-01-01Class II
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
Amedra Pharmaceuticals LLC
Hazard
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Sold states
Nationwide
Affected count
10,992 bottles
Manufactured in
2 Walnut Grove Dr, Suite 190, Horsham, PA, United States
Products
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-385-2014Don't want to check this manually?
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