Drug 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.
D-0445-2025
Product summary
- Firm
- KVK Tech, Inc.
- Event
- Event 96847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9107 bottles
- Official record key
drug-enforcement:D-0445-2025
Official wording
Reason: cGMP deviations
Code information: Lot#: 18400A, Exp 7/31/2027
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations