Indomethacin Capsule, Extended Release
FDA Recall NDC 10702-016
Latest: Class II · Status: Ongoing · Initiated May 09, 2025 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Indomethacin (NDC 10702-016). A significant event, classified as Class II, was initiated on May 09, 2025 by Kvk-tech, Inc.. The reported reason for this action was: "cGMP deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP deviations
May 09, 2025
May 28, 2025
9107 bottles
Recall Profile & Regulatory Data
Event ID
96847
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
KVK Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
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.
Batch or Lot Expiration Information
Lot# : 18400A, Exp 7/31/2027
Affected Packages Involved in this Recall
10702-016-03Indomethacin
10702-016-06Indomethacin
10702-016-09Indomethacin
10702-016-01Indomethacin
10702-016-50Indomethacin
10702-016-10Indomethacin
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
