Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE
Reason Lack of Assurance of Sterility
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
What was recalled
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0604-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Zinc recalls
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Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
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