Medications & Supplements/Topical Products

Calcipotriene Scalp Solution Recalled for Defective Delivery System

Agency Publication Date: June 29, 2022

Summary

Akorn, Inc. has recalled 2,736 bottles of Calcipotriene Topical Solution, 0.005% (Scalp Solution), a prescription medication used to treat skin conditions. The product is being recalled because of a potential defect in the delivery system that could prevent the solution from dispensing correctly. No injuries or incidents have been reported, and consumers should consult a healthcare provider if they have concerns about their treatment.

Risk

A defective delivery system may prevent the medication from being dispensed as intended, which could lead to an interruption in the patient's treatment and a failure to manage their scalp condition.

What You Should Do

The recalled product is Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, sold in 60 mL (2 fl. oz.) bottles under NDC 50383-732-02.
Check the bottle or carton for lot number 378440 and an expiration date of 07/31/2023 to determine if your product is affected.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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: Calcipotriene Topical Solution, 0.005% (Scalp Solution) (60 mL)

Variants: Rx only, Topical Solution

Lot Numbers:

378440 (Exp 07/31/2023)

NDC:

50383-732-02

Manufactured by HI-TECH PHARMACAL CO., INC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90442

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 2,736 Bottles

Distributed To: Nationwide

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

The recalled product is Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, sold in 60 mL (2 fl. oz.) bottles under NDC 50383-732-02.

Check the bottle or carton for lot number 378440 and an expiration date of 07/31/2023 to determine if your product is affected.

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 the manufacturer for further instructions.

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