Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharm
Summary
The FDA issued a Class II for Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, R by ALEMBIC PHARMACEUTICALS, INC.. Reason: Defective Delivery System.
Details
Source
Drug Recall
External ID
D-0941-2023
Action Date
2023-08-02
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: 220151, 220152, 220153, Exp. Date 11/2024
Quantity Affected: 2844 units
Reason for Recall
Defective Delivery System
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-22
Company
Bedminster, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ALEMBIC PHARMACEUTICALS, INC. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ALEMBIC PHARMACEUTICALS, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ALEMBIC PHARMACEUTICALS, INC. have FDA actions?
ALEMBIC PHARMACEUTICALS, INC. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0941-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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