D-0941-2023 Class II Ongoing

Recalled by ALEMBIC PHARMACEUTICALS, INC. — Bedminster, NJ

Recall Details

Product Type
Drugs
Report Date
August 2, 2023
Initiation Date
June 22, 2023
Termination Date
N/A
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