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.
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