Exact FDA event identifier

Event 92581

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

Event summary

Timeline bucket: June 22, 2023
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: ALEMBIC PHARMACEUTICALS, 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

Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12

D-0941-2023

Recall number: D-0941-2023
Initiated: June 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ALEMBIC PHARMACEUTICALS, INC.
Quantity: 2844 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Delivery System

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System

Code information

Lot #: 220151, 220152, 220153, Exp. Date 11/2024

Distribution pattern

Nationwide within the United States