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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84561

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

Open FDA event record

Event summary

Timeline bucket
December 20, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Island Kinetics, Inc. d.b.a. CoValence Laboratories

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

PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.

D-0634-2020
Recall number
D-0634-2020
Initiated
December 20, 2019
Classification
Class III
Status
Terminated
Quantity
2542 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: Salicylic acid content is above the firm's specification.

Code information

Batch number: L041918A, Exp. 04/2021 Lot # F9518B2

Distribution pattern

AZ

Field note

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