KVK-Tech, Inc. recalls Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8)
Recalled September 2, 2015 · FDA recall D-1371-2015 · KVK-Tech
Hazard
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station · FDA Class III
Units
9,696 bottles (100-count), 972 bottles (1000-count)
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Product
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
Manufacturer(s)
KVK-Tech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →