Recalls / Class II
Class IID-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
- Brand name
- Oxybutynin Chloride
- Generic name
- Oxybutynin Chloride
- Active ingredient
- Oxybutynin Chloride
- Route
- Oral
- NDC
- 10702-201
- FDA application
- ANDA209335
- Affected lot / code info
- Lot #: 15079A, Exp 10/20
Why it was recalled
Labeling: Wrong bar code
Recalling firm
- Firm
- KVK-Tech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 156 bottles
- Distribution pattern
- Product was distributed by 10 major distributors throughout the United States.
Timeline
- Recall initiated
- 2018-12-11
- FDA classified
- 2018-12-19
- Posted by FDA
- 2018-12-26
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0340-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.