Class IIReported 2025-05-28

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.

Recalled by KVK Tech, Inc.

Reason for Recall

cGMP deviations

Recall Number

D-0445-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-05-09

Reported

2025-05-28

Distribution

Nationwide

Code Info

Lot#: 18400A, Exp 7/31/2027

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.