Reported May 23, 2018 · Terminated
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Boiron Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boiron Inc. · 6 Campus Blvd · Newtown Square, PA · 19073-3200
Is this the product you have?
- Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
- Lot codes and dates
- Lot Numbers
M7090711M7090712M7090713M7090709M7090807
- Exp09/2019 and M7110589
- Exp11/2019
- Lot Numbers
- Amount recalled
- 52,810 tubes
Where it was sold
- 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%.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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