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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87052

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

Open FDA event record

Event summary

Timeline bucket
December 28, 2020
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Sunstar Americas, 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

Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL

D-0222-2021
Recall number
D-0222-2021
Initiated
December 28, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Sunstar Americas, Inc.
Quantity
a) 1,021,914 bottles; b) 255,552 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
Burkholderia cepacia complex (BCC) contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions

Code information

ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

Distribution pattern

Nationwide USA