Why it was recalled
cGMP deviations
Product description
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
Lot numbers, UPCs & expiration codes
Lot#: 18400A, Exp 7/31/2027
Where it was sold
Nationwide
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-0445-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 9, 2025
- FDA report date
- May 28, 2025
- Quantity
- 9107 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KVK Tech, Inc.
Original FDA data
Every field from FDA enforcement report D-0445-2025, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 96847
- Address
- 110 Terry Dr
- Code information
- Lot#: 18400A, Exp 7/31/2027
- Postal code
- 18940-3427
- Report date
- May 28, 2025
- Product type
- Drugs
- Recall number
- D-0445-2025
- Classification
- Class II
- Recalling firm
- KVK Tech, Inc.
- Product quantity
- 9107 bottles
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 9, 2025
- Initial firm notification
- Center classification date
- May 21, 2025