Home / Recalls / Amedra Pharmaceuticals LLC / D-385-2014

D-385-2014 Class II Terminated

Recalled by Amedra Pharmaceuticals LLC — Horsham, PA

Recall Details

Product Type
Drugs
Report Date
January 1, 2014
Initiation Date
October 7, 2013
Termination Date
October 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,992 bottles

Product 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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot# 243459; Exp. 01/14

Other recalls by Amedra Pharmaceuticals LLC

  • D-173-2013 Class II — Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, (December 4, 2012)
  • D-172-2013 Class II — Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, (December 4, 2012)
  • D-171-2013 Class II — Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, (December 4, 2012)