FDA recall D-528-2013

Product

Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16

Reason for recall

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Distribution

FL, MS, SC, LA and TX

Key facts

Status

Terminated

Initiation date

2013-01-30

Report date

2013-06-12

Termination date

2016-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brooksville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-528-2013