Why it was recalled
Labeling: Wrong bar code
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
Lot numbers, UPCs & expiration codes
Lot #: 15079A, Exp 10/20
Where it was sold
Product was distributed by 10 major distributors throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0340-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 11, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 156 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KVK-Tech, Inc.
Original FDA data
Every field from FDA enforcement report D-0340-2019, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81804
- Address
- 110 Terry Dr
- Code information
- Lot #: 15079A, Exp 10/20
- Postal code
- 18940-3427
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0340-2019
- Classification
- Class II
- Recalling firm
- KVK-Tech, Inc.
- Product quantity
- 156 bottles
- Termination date
- May 1, 2019
- Reason for recall
- Labeling: Wrong bar code
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed by 10 major distributors throughout the United States.
- Recall initiation date
- Dec 11, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 19, 2018