Boiron Inc. is recalling approximately 52,810 tubes of Calendula Cream (calendula officinalis 1X HUS-10%) because of a labeling error regarding the product's strength. The outer cardboard carton incorrectly lists the active ingredient concentration as 7%, while the tube inside correctly identifies it as 10%. This recall affects 2.5 oz. tubes distributed nationwide. If you have this product, you should contact your healthcare provider or pharmacist for guidance regarding the labeling discrepancy.
The outer packaging understates the actual strength of the active ingredient (7% vs. the actual 10%), which could lead to confusion about the product's potency. While the internal tube is labeled correctly, the mismatch between the box and the tube represents a significant labeling error.
Contact healthcare provider and return product to pharmacy.
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Sources: FDA iRES · Raw API Response
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