Drugplain

Diclofenac Sodium Topical Solution 20 mg/g

Diclofenac Sodium Topical Solution · SOLUTION · Direct_Rx

9 Recalls on Record
Plain English

Diclofenac Sodium Topical Solution is a solution containing diclofenac sodium topical solution at 20 mg/g, taken topical. Manufactured by Direct_Rx.

Key Facts

Brand Name
Diclofenac Sodium Topical Solution
Generic Name
Diclofenac Sodium Topical Solution
NDC Code (Product)
72189-546
Manufacturer
Direct_Rx
Strength
20 mg/g
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
ANDA213040
Marketing Start
04/10/2024

Recall History

9 Recalls on Record
Class II12/07/2021

Direct Rx

Defective Container: Leaking containers.

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II10/19/2021

Teligent Pharma, Inc.

Defective Container

TerminatedVoluntary: Firm initiated
Class II03/24/2022

Preferred Pharmaceuticals, Inc.

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class III03/18/2019

Ingenus Pharmaceuticals Llc

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II10/19/2021

Teligent Pharma, Inc.

Defective Container

TerminatedVoluntary: Firm initiated
Class II06/22/2023

ALEMBIC PHARMACEUTICALS, INC.

Defective Delivery System

OngoingVoluntary: Firm initiated
Class II11/29/2021

Preferred Pharmaceuticals, Inc.

Defective container: Out of specification for container integrity leading to bottles leaking.

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is Diclofenac Sodium Topical Solution used for?

Diclofenac Sodium Topical Solution contains Diclofenac Sodium Topical Solution. It is a solution taken topical. Consult your doctor for specific uses.

Is Diclofenac Sodium Topical Solution a controlled substance?

Diclofenac Sodium Topical Solution is not classified as a controlled substance by the DEA.

What is the generic name for Diclofenac Sodium Topical Solution?

The generic name for Diclofenac Sodium Topical Solution is Diclofenac Sodium Topical Solution. There are no other listed brand versions of Diclofenac Sodium Topical Solution.

What is the NDC code for Diclofenac Sodium Topical Solution 20 mg/g?

The NDC (National Drug Code) for Diclofenac Sodium Topical Solution 20 mg/g is 72189-546, listed by Direct_Rx.

Product NDC

72189-546

Package NDC

72189-546-04

Other Diclofenac Sodium Topical Solution Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)