June 2023 FDA Recall Diclofenac Sodium by Alembic Pharmaceuticals, Inc.
D-0941-2023 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Alembic Pharmaceuticals, Inc. on June 22, 2023 for the product Diclofenac Sodium. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0941-2023
Defective Delivery System
06-22-2023
08-02-2023
2844 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
ALEMBIC PHARMACEUTICALS, INC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 220151, 220152, 220153, Exp. Date 11/2024
