FDA recall D-0574-2016

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 for recall

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

Key facts

Status

Terminated

Initiation date

2015-07-21

Report date

2016-01-27

Termination date

2016-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oklahoma City, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2016