FDA recall D-0982-2017

Product

PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981

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-0982-2017