Drug product
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
D-0803-2018
Product summary
- Firm
- Boiron Inc.
- Event
- Event 79846
- Status
- Terminated
- Classification
- Class III
- Quantity
- 52,810 tubes
- Official record key
drug-enforcement:D-0803-2018
Official wording
Reason: 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%.
Code information: Lot Numbers: M7090711, M7090712, M7090713, M7090709, M7090807, Exp: 09/2019 and M7110589, Exp: 11/2019
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Labeling Error