PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: August 2, 2023 Initiated: June 22, 2023 #D-0941-2023

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

Details

Units Affected
2844 units
Distribution
Nationwide within the United States
Location
Bedminster, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by ALEMBIC PHARMACEUTICALS, INC.. Units affected: 2844 units.
Why was this product recalled?
Defective Delivery System
Which agency issued this recall?
This recall was issued by the FDA Drug on August 2, 2023. Severity: Moderate. Recall number: D-0941-2023.