FDA recall D-0803-2018

Product

Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA

Reason for recall

Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-04-13

Report date

2018-05-23

Termination date

2020-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newtown Square, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2018