Medications & Supplements/Topical Products

Teligent Pharma Diclofenac Sodium Solution Recalled for Defective Containers

Agency Publication Date: November 23, 2021

Summary

Teligent Pharma, Inc. is recalling 8,064 bottles of Diclofenac Sodium Topical Solution USP, 1.5% w/w, due to reports of defective containers. This prescription medication, used to treat pain, is being recalled because the packaging may be compromised. No injuries or incidents have been reported in connection with this defect, but a compromised container could affect the medication's quality.

Risk

A defective container may leak or allow the topical solution to be exposed to air, potentially reducing the effectiveness of the medication or causing irritation if the product is contaminated.

What You Should Do

This recall affects Diclofenac Sodium Topical Solution USP, 1.5% w/w, sold in 5 fl oz (150 mL) plastic bottles under the Teligent Pharma brand.
Identify if your medication is affected by checking the NDC and lot numbers on the bottle label. Recalled products include NDC 52565-002-05 (Lot 15188, Exp 2/2023) and NDC 70512-025-05 (Lots 15028, Exp 1/2023 or 15379, Exp 3/2023).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teligent Pharma, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Diclofenac Sodium Topical Solution USP, 1.5% w/w (5 fl oz)

Variants: 1.5% w/w, Topical Solution

Lot Numbers:

15188 (Exp 2/2023)

NDC:

52565-002-05

Quantity: 2664 bottles

Product: Diclofenac Sodium Topical Solution USP, 1.5% w/w (5 fl oz)

Variants: 1.5% w/w, Topical Solution

Lot Numbers:

15028 (Exp 1/2023)

15379 (Exp 3/2023)

NDC:

70512-025-05

Quantity: 5400 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88884

Status: Resolved

Manufacturer: Teligent Pharma, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (2664 bottles; 5400 units)

Distributed To: Nationwide

Agency Last Updated: December 14, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Diclofenac Sodium Topical Solution USP, 1.5% w/w, sold in 5 fl oz (150 mL) plastic bottles under the Teligent Pharma brand.

Identify if your medication is affected by checking the NDC and lot numbers on the bottle label. Recalled products include NDC 52565-002-05 (Lot 15188, Exp 2/2023) and NDC 70512-025-05 (Lots 15028, Exp 1/2023 or 15379, Exp 3/2023).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teligent Pharma, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Diclofenac Sodium Topical Solution USP, 1.5% w/w (5 fl oz)

Variants: 1.5% w/w, Topical Solution

Lot Numbers:

15188 (Exp 2/2023)

NDC:

52565-002-05

Quantity: 2664 bottles

Product: Diclofenac Sodium Topical Solution USP, 1.5% w/w (5 fl oz)

Variants: 1.5% w/w, Topical Solution

Lot Numbers:

15028 (Exp 1/2023)

15379 (Exp 3/2023)

NDC:

70512-025-05

Quantity: 5400 units