Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
Reported: August 23, 2017 Initiated: August 3, 2017 #D-1083-2017
Product Description
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
Reason for Recall
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Details
- Recalling Firm
- KVK-Tech, Inc.
- Units Affected
- 35,267 bottles
- Distribution
- Nationwide in the United States
- Location
- Newtown, PA
Frequently Asked Questions
What product was recalled? ▼
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940. Recalled by KVK-Tech, Inc.. Units affected: 35,267 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 23, 2017. Severity: Low. Recall number: D-1083-2017.
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