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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87081

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

Open FDA event record

Event summary

Timeline bucket
January 01, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Precision Dose 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

Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.

D-0228-2021
Recall number
D-0228-2021
Initiated
January 01, 2021
Classification
Class II
Status
Terminated
Recalling firm
Precision Dose Inc.
Quantity
1,107,510 unit dose cups

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: The firm was notified of the manufacturer's expanded recall.

Code information

Lot #: a) 502037, 502040, 502043, Exp 1/31/2021; 502494, 502757, Exp 8/31/2021; 502677, Exp 9/30/2021; 502693, 502728, Exp 10/31/2021; 502771, 502784, Exp 11/30/2021; 502824, Exp 12/31/2021; 502925, Exp 2/28/2022; b) 502037, 502040, 502043, Exp 1/31/2021; 502494, Exp 8/31/2021; 502759, Exp 10/31/2021; 502771, Exp 11/30/2021

Distribution pattern

Nationwide USA