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Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newto...

FDA Recall #D-0340-2019 — Class II — December 11, 2018

Recall #D-0340-2019 Date: December 11, 2018 Classification: Class II Status: Terminated

Product Description

Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50

Reason for Recall

Labeling: Wrong bar code

Recalling Firm

KVK-Tech, Inc. — Newtown, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

156 bottles

Distribution

Product was distributed by 10 major distributors throughout the United States.

Code Information

Lot #: 15079A, Exp 10/20

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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