Exact FDA event identifier

Event 64149

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

Event summary

Timeline bucket: January 23, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Mission Pharmacal Co

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

Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE

D-602-2013

Recall number: D-602-2013
Initiated: January 23, 2013
Classification: Class III
Status: Terminated
Recalling firm: Mission Pharmacal Co
Quantity: 8,437 bottles

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 product active ingredients were formulated incorrectly (too high) with respect to the label strength.

Code information

Lot# E112, Exp 05/14 Lot# J062, Exp 09/14

Distribution pattern

Nationwide