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Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Tr...

FDA Recall #D-0111-2018 — Class III — December 18, 2017

Recall #D-0111-2018 Date: December 18, 2017 Classification: Class III Status: Terminated

Product Description

Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10

Reason for Recall

Subpotent Drug

Recalling Firm

Osmotica Pharmaceutical Corp — Marietta, GA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

9919 bottles

Distribution

Nationwide

Code Information

Lot #: 170029A, Exp. 02/2019; 170030A, Exp. 02/2019

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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