Medications & Supplements/Topical Products

SOLA Diclofenac Sodium Topical Solution Recalled for Leaking Bottles

Agency Publication Date: December 13, 2021

Summary

Preferred Pharmaceuticals, Inc. has recalled 72 bottles of SOLA brand Diclofenac Sodium Topical Solution (1.5% w/w), a prescription medication used for pain relief. The recall was issued because the 150 mL bottles were found to have a container defect that causes them to leak. No injuries or medical incidents have been reported to date, but consumers who received this medication from their physician should seek guidance from their healthcare provider.

Risk

The leaking bottles can result in the loss of medication, leading to an incorrect or insufficient dose. Additionally, a compromised container seal may allow environmental contaminants to enter the bottle or cause unintended exposure to the drug solution.

What You Should Do

The recalled product is SOLA Pharmaceuticals Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles with NDC 68788-7707-01 and Lot number E1220B.
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 Preferred Pharmaceuticals, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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, 1.5% w/w (150 mL)by SOLA Pharmaceuticals

Variants: 1.5% w/w, Topical Solution

Lot Numbers:

E1220B

NDC:

68788-7707-01

Recall #: D-0278-2022; Rx only; Mfg: SOLA Pharmaceuticals

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89143

Status: Active

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: Physician consignees

Manufactured In: United States

Units Affected: 72 bottles

Distributed To: Connecticut, Florida, Kansas

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.