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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69141

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

Open FDA event record

Event summary

Timeline bucket
August 27, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sage Products 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

Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013

D-1573-2014
Recall number
D-1573-2014
Initiated
August 27, 2014
Classification
Class II
Status
Terminated
Recalling firm
Sage Products Inc
Quantity
8-ct. 7,066 cases; 24-ct. 2,664 cases

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.

Code information

Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15

Distribution pattern

Nationwide

Field note

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