D-0803-2018 Class III Terminated
FDA drug recall D-0803-2018 was initiated by Boiron Inc. on April 13, 2018 and is designated Class III. 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) cor… The recall status is terminated (terminated January 8, 2020). Affected quantity: 52,810 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 23, 2018
- Initiation Date
- April 13, 2018
- Termination Date
- January 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52,810 tubes
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%.
Distribution Pattern
Nationwide
Code Information
Lot Numbers: M7090711, M7090712, M7090713, M7090709, M7090807, Exp: 09/2019 and M7110589, Exp: 11/2019