Exact FDA event identifier

Event 80876

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

Event summary

Timeline bucket: August 23, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Pfizer Global Supply

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0

D-1169-2018

Recall number: D-1169-2018
Initiated: August 23, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pfizer Global Supply
Quantity: 17,136 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.

Code information

Lot #: R51129, Exp. 11/20

Distribution pattern

Nationwide within the United States