Exact FDA event identifier

Event 61934

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

Event summary

Timeline bucket: March 16, 2012
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Ranbaxy 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

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

Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08

D-1405-2012

Recall number: D-1405-2012
Initiated: March 16, 2012
Classification: Class III
Status: Terminated
Recalling firm: Ranbaxy Inc.
Quantity: 2544 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.

Code information

Lot #: RB81031, Exp 01/13

Distribution pattern

Nationwide