FDAClass IIAugust 12, 2015

Dextroamphetamine Saccharate recall: Impurity Out of Spec

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single…

Why was Dextroamphetamine Saccharate recalled?

Failed Impurities/Degradation Specifications: out of specification for unknown impurity

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 #: 34015862A, Exp. Date 6/2016 Lot #: 34016376A, Exp. Date 7/2016

Product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single…
Recalling firm
Teva Pharmaceuticals USA
Quantity
19,504 bottles
Distribution
Nationwide
Recall date
August 12, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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