FDAClass IIAugust 14, 2013

Methylphenidate Hydrochloride Extended-Release Capsules recall: Failed Dissolution

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01

Why was Methylphenidate Hydrochloride Extended-Release Capsules recalled?

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

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?

34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.

Product
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
Recalling firm
Teva Pharmaceuticals USA, Inc.
Quantity
13,478 bottles
Distribution
Nationwide
Recall date
August 14, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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