A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10% recalled over undeclared excipients
- Recall date
- February 21, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Bayer HealthCare Pharmaceuticals, Inc. recalls A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 o…
- Recall number
- D-0604-2017
- FDA classification
- Class III
- Brand / firm
- Bayer HealthCare Pharmaceuticals, Inc.
- Sold / distributed
- US Nationwid, Puerto Rico, and Iceland
Why it was recalled
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Class III means the product violates regulations but is not likely to cause harm.
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
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