FDA recall D-0345-2018

Product

Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-602-16.

Reason for recall

Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2018-01-26

Report date

2018-02-21

Termination date

2019-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Scottsdale, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0345-2018