D-0052-2018 Class III Terminated

Recalled by Teva Pharmaceuticals USA — North Wales, PA

Recall Details

Product Type
Drugs
Report Date
November 1, 2017
Initiation Date
October 17, 2017
Termination Date
April 12, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58,292 bottles

Product Description

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

Reason for Recall

Failed Dissolution Specifications: Low out of specification results for dissolution.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot Number # 1156086M, Exp 08/18