Recall: D-0574-2016

Class III - Minor Violations

Class IIIClassification

2015-07-21Initiated

TerminatedStatus

PD-Rx Pharmaceuticals, Inc.Firm

Product

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.

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.