Exact FDA event identifier

Event 65349

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

Event summary

Timeline bucket: May 28, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Faria Limited LLC dba Sheffield Pharmaceuticals

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)

D-604-2013

Recall number: D-604-2013
Initiated: May 28, 2013
Classification: Class III
Status: Terminated
Recalling firm: Faria Limited LLC dba Sheffield Pharmaceuticals
Quantity: 105,744 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Unable to meet shelf life expiry.

Code information

Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14

Distribution pattern

PA, GA, WA, CA