FDA recall D-1162-2017

Product

Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30

Reason for recall

Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

Distribution

Distributed to the state of CA and NV.

Key facts

Status

Terminated

Initiation date

2017-09-05

Report date

2017-09-20

Termination date

2019-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1162-2017