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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95250

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

Open FDA event record

Event summary

Timeline bucket
August 28, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PREQUEL SKIN

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

BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4

D-0657-2024
Recall number
D-0657-2024
Initiated
August 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
PREQUEL SKIN
Quantity
30,946 tubes

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 -

Code information

Lot: X4054A, Exp: 2/2026; X4136A, X4137A, X4138A, Exp: 5/2026

Distribution pattern

Distributed nationwide in USA and on line