Class II
Terminated
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
This recall has been terminated (originally issued March 6, 2013).
- Company
- Amedra Pharmaceuticals Llc
- Recall Initiated
- December 4, 2012
- Posted
- March 6, 2013
- Recall Number
- D-171-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,176 bottles
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Distribution
Nationwide and Puerto Rico.
Lot / Code Info
Lot 238316, exp 01/31/2014
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