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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62983

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

Open FDA event record

Event summary

Timeline bucket
August 17, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Axcentria Pharmaceuticals LLC

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

Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03

D-134-2013
Recall number
D-134-2013
Initiated
August 17, 2012
Classification
Class III
Status
Terminated
Quantity
17,679 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Stability data does not support expiration

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.

Code information

Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.

Distribution pattern

MI