drugs Class II Updated 2014-01-01

Amedra Pharmaceuticals LLC recalls Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained

Recalled Product

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

Hazard / Issue

Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot# 243459; Exp. 01/14
View official government recall

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