FDA-Drug2017-03-29Class III

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

Bayer HealthCare Pharmaceuticals, Inc.
Hazard

Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.

Sold states
US Nationwid, Puerto Rico, and Iceland
Affected count
a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz)
Manufactured in
36 Columbia Rd, Morristown, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0604-2017

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