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FDAFDA · Food and drugs·Recall number D-848-2013

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

Published August 14, 2013 · Recall initiated: June 18, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
METHYLPHENIDATE HYDROCHLORIDE
Manufacturer
Teva Pharmaceuticals USA, Inc.
Distributor
Nationwide
Lot
34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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