FDAClass IIIMarch 13, 2013

Dextroamphetamine Saccharate recall: Failed Dissolution

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx…

Why was Dextroamphetamine Saccharate recalled?

Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.

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 #: 50077231

Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx…
Recalling firm
Actavis Elizabeth LLC
Quantity
9,264 Bottles
Distribution
Nationwide
Recall date
March 13, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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