Why it was recalled
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
US Nationwid, Puerto Rico, and Iceland
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0604-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 21, 2017
- FDA report date
- Mar 29, 2017
- Quantity
- a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0604-2017, exactly as published.
Show all FDA fields
- City
- Morristown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76585
- Address
- 36 Columbia Rd
- Code information
- 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.
- Postal code
- 07960-4526
- Report date
- Mar 29, 2017
- Product type
- Drugs
- Recall number
- D-0604-2017
- Classification
- Class III
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Inc.
- Product quantity
- a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz)
- Termination date
- Jan 3, 2018
- Reason for recall
- Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- US Nationwid, Puerto Rico, and Iceland
- Recall initiation date
- Feb 21, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2017