Multi event Drug Recall Enforcement Report Class II voluntary initiated by KVK Tech, Inc., originally initiated on 05-09-2025 for the product 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. The product was recalled due to cgmp deviations. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0445-2025 | 05-09-2025 | 05-28-2025 | Class II | 9107 bottles | 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. | cGMP deviations | Ongoing |
| D-0446-2025 | 05-09-2025 | 05-28-2025 | Class II | 9680 bottles | Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01. | cGMP deviations | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 10702-016 | Indomethacin | Indomethacin | Capsule, Extended Release | Oral | Kvk-tech, Inc. | Human Prescription Drug |
| 10702-026 | Phentermine Hydrochloride | Phentermine Hydrochloride | Capsule | Oral | Kvk-tech, Inc. | Human Prescription Drug |
| 10702-027 | Phentermine Hydrochloride | Phentermine Hydrochloride | Capsule | Oral | Kvk-tech, Inc. | Human Prescription Drug |
| 10702-028 | Phentermine Hydrochloride | Phentermine Hydrochloride | Capsule | Oral | Kvk-tech, Inc. | Human Prescription Drug |
