Product Detail

Product Description Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01

Recall Number D-849-2013

Classification Class II

Code Info 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.

Product Distributed Qty 7,579 bottles

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

Event Detail

Event Id 65515

Product Type Drugs

Status Ongoing

Recalling Firm

Teva Pharmaceuticals USA, Inc.
City Sellersville

State PA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-06-18

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide