FDAClass IIMarch 6, 2013

Dextroamphetamine Sulfate Extended Release Capsules recall: Failed Dissolution

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC…

Why was Dextroamphetamine Sulfate Extended Release Capsules recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 220843, exp 11/30/2013

Product
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC…
Recalling firm
Amedra Pharmaceuticals LLC
Quantity
10,968 bottles
Distribution
Nationwide and Puerto Rico.
Recall date
March 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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