FDAFDA · Food and drugs·Recall number D-385-2014
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
Published January 1, 2014 · Recall initiated: October 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amedra Pharmaceuticals LLC
- Distributor
- Nationwide
- Lot
- Lot# 243459; Exp. 01/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States