Why it was recalled
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Product description
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
Lot numbers, UPCs & expiration codes
Lot # 17853A, Exp. 06/30/2027
Where it was sold
Nationwide in the USA and PR
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-0049-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 20, 2023
- FDA report date
- Oct 25, 2023
- Quantity
- 1488 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KVK-Tech, Inc.
Original FDA data
Every field from FDA enforcement report D-0049-2024, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 93101
- Address
- 110 Terry Dr
- Code information
- Lot # 17853A, Exp. 06/30/2027
- Postal code
- 18940-3427
- Report date
- Oct 25, 2023
- Product type
- Drugs
- Recall number
- D-0049-2024
- Classification
- Class I
- Recalling firm
- KVK-Tech, Inc.
- Product quantity
- 1488 bottles
- Termination date
- Jul 29, 2025
- Reason for recall
- Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
- Distribution pattern
- Nationwide in the USA and PR
- Recall initiation date
- Sep 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 18, 2023