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Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Wa...

FDA Recall #D-0052-2018 — Class III — October 17, 2017

Recall #D-0052-2018 Date: October 17, 2017 Classification: Class III Status: Terminated

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.

Recalling Firm

Teva Pharmaceuticals USA — North Wales, PA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

58,292 bottles

Distribution

Nationwide in the USA and Puerto Rico

Code Information

Lot Number # 1156086M, Exp 08/18

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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