Home / Recalls / Amedra Pharmaceuticals LLC / D-172-2013

D-172-2013 Class II Terminated

Recalled by Amedra Pharmaceuticals LLC — Horsham, PA

Recall Details

Product Type
Drugs
Report Date
March 6, 2013
Initiation Date
December 4, 2012
Termination Date
March 21, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,948 bottles

Product Description

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09

Reason for Recall

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

Lot 220839, exp 11/30/2013

Other recalls by Amedra Pharmaceuticals LLC

  • D-385-2014 Class II — Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15m (October 7, 2013)
  • D-173-2013 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)