FDA Recall D-0941-2023

ALEMBIC PHARMACEUTICALS, INC. · Bedminster, NJ

Class II Ongoing 1057 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

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

Quantity: 2844 units

Reason for recall

Defective Delivery System

Recall record

Recall number: D-0941-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2023-06-22
Classified by FDA Center: 2023-07-24
FDA published: 2023-08-02
Recalling firm: ALEMBIC PHARMACEUTICALS, INC.
Firm location: Bedminster, NJ

Drug identification

Brand name(s): DICLOFENAC SODIUM
Generic name(s): DICLOFENAC SODIUM
Manufacturer(s): Alembic Pharmaceuticals Inc.
NDC(s): 62332-487
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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