FDA-Drug2018-05-23Class III
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Boiron Inc.
Hazard
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%.
Sold states
Nationwide
Affected count
52,810 tubes
Manufactured in
6 Campus Blvd, Newtown Square, PA, United States
Products
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2018Don't want to check this manually?
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