PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: May 23, 2018 Initiated: April 13, 2018 #D-0803-2018

Product Description

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%.

Details

Recalling Firm
Boiron Inc.
Units Affected
52,810 tubes
Distribution
Nationwide
Location
Newtown Square, PA

Frequently Asked Questions

What product was recalled?
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA. Recalled by Boiron Inc.. Units affected: 52,810 tubes.
Why was this product 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%.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 23, 2018. Severity: Low. Recall number: D-0803-2018.