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

Recall date

April 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0803-2018

FDA classification

Class III

Brand / firm

Boiron Inc.

Sold / distributed

Nationwide

Why it was recalled

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%.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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