Boiron Recalls Calendula Cream Due to Outer Carton Labeling Error
Boiron Inc. is recalling 52,810 tubes of Calendula Cream because the outer carton incorrectly lists the active ingredient concentration as 7% instead of 10%.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error on the outer carton.
Plain-English summary
Boiron Inc. is recalling 52,810 tubes of Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. The recall is due to a labeling error on the secondary packaging. The outer carton misstates the concentration of the active ingredient as 7%, while the primary packaging (the tube) correctly states the concentration as 10%.
The affected product was distributed nationwide. The recall includes specific lot numbers: M7090711, M7090712, M7090713, M7090709, M7090807 (Exp: 09/2019) and M7110589 (Exp: 11/2019). The U.S. Food and Drug Administration has classified this as a Class III recall.
Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact Boiron Inc. for further instructions.
The recalled product
- Product
- Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
- Manufacturer
- Boiron Inc.
- Category
- Drug — Topical Cream
- Hazard
- Affected units
- 52,810
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers: M7090711
- M7090712
- M7090713
- M7090709
- M7090807
- Exp: 09/2019 and M7110589
- Exp: 11/2019
Distribution
Distributed nationwide across the United States.
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