FDA recall D-1083-2017

Product

Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940

Reason for recall

Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.

Distribution

Nationwide in the United States

Key facts

Status

Terminated

Initiation date

2017-08-03

Report date

2017-08-23

Termination date

2018-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2017