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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86567

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

Open FDA event record

Event summary

Timeline bucket
October 22, 2020
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Aurobindo Pharma USA 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

Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92

D-0065-2021
Recall number
D-0065-2021
Initiated
October 22, 2020
Classification
Class III
Status
Terminated
Recalling firm
Aurobindo Pharma USA Inc.
Quantity
7440 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

Code information

Lot # BO1020080AA3, EXP 7/2023

Distribution pattern

NJ