December 2018 FDA Recall Oxybutynin Chloride by Kvk-tech, Inc.
D-0340-2019 - Labeling
This Class II drug recall was voluntarily initiated by Kvk-tech, Inc. on December 11, 2018 for the product Oxybutynin Chloride. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed by 10 major distributors throughout the United States. and the recall is currently terminated.
Recall Number: D-0340-2019
Labeling: Wrong bar code
12-11-2018
12-26-2018
156 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed by 10 major distributors throughout the United States.
05-01-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50
Batch or Lot Expiration Information
Lot# : 15079A, Exp 10/20
