ALEMBIC PHARMACEUTICALS, INC. recalls Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharm…
- Recall date
- June 22, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0941-2023
- FDA classification
- Class II
- Brand / firm
- ALEMBIC PHARMACEUTICALS, INC.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Defective Delivery System
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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