Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, T...

FDA Recall #D-0110-2018 — Class III — December 18, 2017

Recall #D-0110-2018 Date: December 18, 2017 Classification: Class III Status: Terminated

Product Description

Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10

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

10064 bottles

Distribution

Nationwide

Code Information

Lot #: 170027A, Exp. 02/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated