FDA recall D-0981-2017

Product

Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30

Reason for recall

Failed Dissolution Specifications: Low dissolution results were obtained during stability testing

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-05-24

Report date

2017-07-26

Termination date

2018-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0981-2017