PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: March 29, 2017 Initiated: February 21, 2017 #D-0604-2017

Product Description

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

Reason for Recall

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

Details

Units Affected
a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz)
Distribution
US Nationwid, Puerto Rico, and Iceland
Location
Morristown, NJ

Frequently Asked Questions

What product 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. Recalled by Bayer HealthCare Pharmaceuticals, Inc.. Units affected: a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz).
Why was this product recalled?
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 29, 2017. Severity: Low. Recall number: D-0604-2017.