FDA recall D-1118-2017

PD-Rx Pharmaceuticals, Inc. · Class III · drug

Product

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2017-08-11
Report date: 2017-08-30
Termination date: 2020-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Oklahoma City, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1118-2017