Drug & medication recalls Moderate risk

Indomethacin Extended-Release Capsules USP recalled over manufacturing violations

Recall date
May 9, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
KVK Tech, Inc. recalls Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 189…
Recall number
D-0445-2025
FDA classification
Class II
Brand / firm
KVK Tech, Inc.
Sold / distributed
Nationwide

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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