Recalling firm
KVK Tech, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-05-28
Distribution
Nationwide
Firm state
PA
Product quantity
9107 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP deviations
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.
Code / lot info
Lot#: 18400A, Exp 7/31/2027
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.