FDAHealthMay 9, 2025
KVK Tech, Inc. — 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.
⚠️ cGMP deviations
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 9, 2025
Nationwide
What's affected?
- 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
- INDOMETHACIN
- UPC
- 0310702016101
- Lot code
- 18400A
Additional details
Lot#: 18400A, Exp 7/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 9107 bottles.
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