FDA recall D-0604-2017

Product

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.

Distribution

US Nationwid, Puerto Rico, and Iceland

Key facts

Status

Terminated

Initiation date

2017-02-21

Report date

2017-03-29

Termination date

2018-01-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morristown, NJ, United States

Primary source

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