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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76585

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 21, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bayer HealthCare Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0604-2017
Recall number
D-0604-2017
Initiated
February 21, 2017
Classification
Class III
Status
Terminated
Quantity
a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

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.

Distribution pattern

US Nationwid, Puerto Rico, and Iceland

Field note

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