Reported Jan 1, 2014 · Terminated
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only,…
Amedra Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amedra Pharmaceuticals LLC · 2 Walnut Grove Dr · Horsham, PA · 19044-2219
Is this the product you have?
- 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
- Lot codes and dates
Lot# 243459Exp. 01/14
- Amount recalled
- 10,992 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
This product could cause temporary or reversible health problems — stop using it.
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