KVK-Tech, Inc. recalls Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (ND…
- Recall date
- August 3, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1083-2017
- FDA classification
- Class III
- Brand / firm
- KVK-Tech, Inc.
- Sold / distributed
- Nationwide in the United States
Why it was recalled
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Class III means the product violates regulations but is not likely to cause harm.
What 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
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