Recalls / Class II
Class IID-0445-2025
Product
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.
- Brand name
- Indomethacin
- Generic name
- Indomethacin
- Active ingredient
- Indomethacin
- Route
- Oral
- NDC
- 10702-016
- FDA application
- ANDA079175
- Affected lot / code info
- Lot#: 18400A, Exp 7/31/2027
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- KVK Tech, Inc.
- Manufacturer
- KVK-Tech, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, N/A, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 9107 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-05-09
- FDA classified
- 2025-05-21
- Posted by FDA
- 2025-05-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0445-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.