D-0445-2025 Class II Ongoing

Recalled by KVK Tech, Inc. — Newtown, PA

Recall Details

Product Type
Drugs
Report Date
May 28, 2025
Initiation Date
May 9, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9107 bottles

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

Distribution Pattern

Nationwide

Code Information

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