FDA-Drug2023-08-02Class II

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

ALEMBIC PHARMACEUTICALS, INC.
Hazard

Defective Delivery System

Sold states
Nationwide within the United States
Affected count
2844 units
Manufactured in
550 Hills Dr Ste 104b, N/A, Bedminster, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0941-2023

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