Recalls / Class III
Class IIID-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
- Affected lot / code info
- 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.
Why it was recalled
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Recalling firm
- Firm
- Bayer HealthCare Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Columbia Rd, Morristown, New Jersey 07960-4526
Distribution
- Quantity
- a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz)
- Distribution pattern
- US Nationwid, Puerto Rico, and Iceland
Timeline
- Recall initiated
- 2017-02-21
- FDA classified
- 2017-03-21
- Posted by FDA
- 2017-03-29
- Terminated
- 2018-01-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0604-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.