Calendula Cream recall: Labeling Error
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Why was Calendula Cream 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%.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: M7090711, M7090712, M7090713, M7090709, M7090807, Exp: 09/2019 and M7110589, Exp: 11/2019
- Product
- Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
- Recalling firm
- Boiron Inc.
- Quantity
- 52,810 tubes
- Distribution
- Nationwide
- Recall date
- May 23, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)