Diclofenac Sodium Solution
FDA Recall NDC 62332-487
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Diclofenac Sodium (NDC 62332-487). A significant event, classified as Class II, was initiated on Jun 22, 2023 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "Defective Delivery System"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective Delivery System
Jun 22, 2023
Aug 02, 2023
2844 units
Recall Profile & Regulatory Data
Event ID
92581
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ALEMBIC PHARMACEUTICALS, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 220151, 220152, 220153, Exp. Date 11/2024
Affected Packages Involved in this Recall
62332-487-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
