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…

Recall date

July 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1371-2015

FDA classification

Class III

Brand / firm

KVK-Tech, Inc.

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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