Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, ...
FDA Recall #D-0445-2025 — Class II — May 9, 2025
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.
Reason for Recall
cGMP deviations
Recalling Firm
KVK Tech, Inc. — Newtown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9107 bottles
Distribution
Nationwide
Code Information
Lot#: 18400A, Exp 7/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated