FDA recall D-0340-2019

Product

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-12-11

Report date

2018-12-26

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0340-2019