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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77591

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

Open FDA event record

Event summary

Timeline bucket
June 13, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sigan Industries 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

CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033

D-0975-2017
Recall number
D-0975-2017
Initiated
June 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sigan Industries Inc.
Quantity
19,608 tubes

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination
Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non Sterile Products; out of specification Total Plate Count

Code information

lot number 17-01319, exp 01/19

Distribution pattern

CA

Field note

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