Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0340-2019

December 11, 2018

Class II

Product summary

Firm
KVK-Tech, Inc.
Event
Event 81804
Status
Terminated
Classification
Class II
Quantity
156 bottles
Official record key
drug-enforcement:D-0340-2019

Official wording

Reason: Labeling: Wrong bar code

Code information: Lot #: 15079A, Exp 10/20

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Wrong