FDA recall D-0445-2025
KVK Tech, Inc. · Class II · 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.
Reason for recall
cGMP deviations
Distribution
Nationwide
Key facts
- Status
- Ongoing
- Initiation date
- 2025-05-09
- Report date
- 2025-05-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Newtown, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2025