Home / Recalls / ALEMBIC PHARMACEUTICALS, INC. / D-0941-2023

D-0941-2023 Class II Ongoing

Recalled by ALEMBIC PHARMACEUTICALS, INC. — Bedminster, NJ

FDA drug recall D-0941-2023 was initiated by ALEMBIC PHARMACEUTICALS, INC. on Jun 22, 2023 and is designated Class II. Reason for recall: Defective Delivery System The recall status is ongoing. Affected quantity: 2844 units.

Recall Details

Product Type: Drugs
Report Date: Aug 2, 2023
Initiation Date: Jun 22, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2844 units

Product Description

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

Reason for Recall

Defective Delivery System

Distribution Pattern

Nationwide within the United States

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0941-2023
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.