PD-Rx Pharmaceuticals, Inc. recalls Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-1…

Recall date

July 21, 2015

Source

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

Recall number

D-0574-2016

FDA classification

Class III

Brand / firm

PD-Rx Pharmaceuticals, 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) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.