D-0445-2025 Class II Ongoing
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