🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: October 7, 2013 Amedra Pharmaceuticals Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot# 243459; Exp. 01/14
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Amedra Pharmaceuticals LLC
Reason for Recall:
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot# 243459; Exp. 01/14

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-385-2014

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