February 2017 FDA Recall Drug by Bayer Healthcare Pharmaceuticals, Inc.
D-0604-2017 - Labeling

This Class III drug recall was voluntarily initiated by Bayer Healthcare Pharmaceuticals, Inc. on February 21, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in US Nationwid, Puerto Rico, and Iceland and the recall is currently terminated.

Recall Number: D-0604-2017

Reason for Recall
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Initiated
02-21-2017
Reported
03-29-2017
Quantity
a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76585
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bayer HealthCare Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwid, Puerto Rico, and Iceland
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-03-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# a)
Lot# : CV0068D, Exp. 12/31/2018; CV008N6, Exp. 2/28/2019; CV008N7, Exp. 3/31/2019; CV00BJA, Exp. 6/30/2019; CV00D0V and CV00DM4, Exp.8/31/2019. b)
Lot# : CV0068G, Exp. 12/31/2018; CV008N9, Exp. 3/31/2019; CV008N8, Exp. 4/30/2019; CV00D0U, Exp. 8/31/2019 and CV00G4U, Exp.10/31/2019. c)
Lot# : CV0068M, Exp. 12/31/2018; CV0068K, Exp.1/31/2019; CV008N5, Exp. 2/28/2019; CV008NC and CV008NE, Exp. 3/31/2019; CV008ND, CV008NB and CV008NA, Exp.4/30/2019; CV008NH, CV008NG and CV008NJ, Exp. 05/31/2019; CV00BJC, Exp.6/30/2019; CV00BJB, CV00BJE, CV00BJD, CV00BXB, CV00BXA and CV00BX9, Exp.7/31/2019; CV00D7H, CV00D7G, CV00D7E and CV00D7J, Exp. 8/31/2019; CV00E5T, CV00E5S and CV00E5R, Exp. 9/30/19; CV00G69 and CV00G6B, Exp.10/31/2019.