October 2019 FDA Recall Drug by Kvk-tech, Inc.
D-0142-2020 - Presence of Foreign Substance; Fiber particles.

This Class III drug recall was voluntarily initiated by Kvk-tech, Inc. on October 4, 2019 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; fiber particles.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0142-2020

Reason for Recall
Presence of Foreign Substance; Fiber particles.
Initiated
10-04-2019
Reported
10-23-2019
Quantity
384 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83851
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KVK-Tech, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-20-2020
Product Description About Product Description
Full technical description of the product.
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.

Batch or Lot Expiration Information

Batch# 15315A, Exp. 02/2021