GlaxoSmithKline Recalls Nearly 600,000 Asthma Inhalers Over Dose Delivery Risks

GlaxoSmithKline (GSK) has voluntarily recalled almost 600,000 Ventolin HFA 200D asthma inhalers in the United States, after discovering that a manufacturing defect could result in the devices delivering fewer doses of medication than indicated. The recall, designated as Class II by the FDA, covers three specific lots distributed to pharmacies, hospitals, wholesalers, and retailers nationwide.

Understanding the Inhaler Recall

The recall centers on Ventolin HFA (albuterol sulfate) Inhalation Aerosol inhalers, a life-sustaining rescue medication commonly prescribed to treat asthma and other obstructive airway diseases. The action was initiated after GSK received numerous product complaints indicating that patients may not receive the labeled number of doses from affected inhalers. The FDA classified the recall as Class II, meaning that use of these products could cause “temporary or medically reversible adverse health consequences” but is not likely to cause lasting harm.

Reason Behind the Recall

According to GSK and multiple regulatory filings, the recall was issued over reports that some inhalers had a

bulging outer wrapper, a sign of internal propellant leakage. Since the propellant is responsible for delivering the medication each time a user actuates the inhaler, any leak could mean the patient receives less than the full prescribed dose during use. This failure poses a significant risk for those relying on these inhalers for life-saving treatment during asthma attacks.

Key Facts About the Recall

• Number of Inhalers Recalled: Over 593,000 units
• Product Affected: Ventolin HFA 200D inhalers (albuterol sulfate)
• Recall Date: March 2017
• FDA Recall Classification: Class II
• Reason: Potential for inhalers to deliver fewer than the stated number of actuations due to propellant leaking
• Recall Scope: Devices removed from hospitals, pharmacies, retailers, and wholesalers; not a consumer-level recall
• Reported Defect: Bulging outer wrappers, indicating propellant loss

Affected Ventolin HFA Lot Numbers

Lot Number	Expiration
6ZP9848	03/18
6ZP0003	04/18
6ZP9944	04/18

If you or someone you know uses a Ventolin HFA 200D inhaler, please verify the lot number on your device to determine if it is included in the recall. The affected items were produced at GSK’s manufacturing plant in North Carolina and may have been distributed across the United States.

Risks Associated With Defective Inhalers

The main risk posed by the recalled inhalers is delivering insufficient doses of medication during an asthma attack or episode of airway constriction. Since albuterol is a fast-acting bronchodilator used to open airways, any reduction in delivery could lead to unrelieved symptoms such as wheezing, coughing, breathlessness, or—in severe cases—life-threatening asthma attacks. Patients may not realize their inhaler is faulty until it fails during use, which underscores the importance of this recall.

Potential Consequences

• Inadequate medication delivery during asthma attacks
• Increased risk of severe asthma symptoms or emergency room visits
• Potential for dangerous respiratory distress if the device fails at a critical moment
• Uncertainty for patients reliant on these inhalers as their primary rescue medication

What Should Patients Do?

While this recall is not designated as a consumer-level (or “patient-level”) recall, patients in possession of affected inhalers should be aware of the following recommendations:

• Check the lot number and expiration date on your Ventolin HFA 200D inhaler.
• If your inhaler is from one of the recalled lots, contact your doctor to discuss alternatives or obtain a replacement device.
• Do not continue using defective inhalers if you feel they are not providing relief—seek prompt medical attention.
• Contact GSK’s customer service center (1-888-825-5249) for more information or if you have questions about your inhaler.
• If you experience worsening symptoms or find the inhaler ineffective, visit your healthcare provider or an emergency room immediately.

Guidance for Healthcare Providers and Pharmacists

• Remove all affected lots from shelves and inventory.
• Notify patients to check their inhalers and offer advice about alternatives.
• Stay updated on recall developments for additional lots or brands if announced.

GSK’s Response and Ongoing Investigation

GlaxoSmithKline has stated that they are actively investigating both the root cause of the leakage issue and working to implement corrective and preventative measures. In a company statement, GSK indicated:

“We continue to investigate the issue in order to identify the root cause and implement appropriate corrective and preventative actions. We currently don’t anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue.”

At this time, the bulk of the recall has involved removing products from the supply chain, and the company does not expect shortages of Ventolin HFA in the U.S. market. However, vigilance from healthcare providers and patients remains critical.

About Ventolin HFA (Albuterol Sulfate) Inhalers

Ventolin HFA inhalers are among the most commonly prescribed rescue asthma inhalers in the US and globally. The active ingredient, albuterol sulfate, acts quickly to relax the muscles of the airways and improve breathing when inhaled. Proper function of the inhaler’s delivery mechanism is therefore essential for effective treatment.

Patients with chronic obstructive pulmonary disease (COPD) also routinely use these inhalers to relieve sudden respiratory symptoms.

How to Check If Your Inhaler is Affected

Follow these steps to determine if your Ventolin HFA inhaler is part of the recall:

• Locate the lot number printed on your device’s packaging or canister label.
• Compare it to the affected lot numbers: 6ZP9848, 6ZP0003, or 6ZP9944.
• Check the expiration date: March 2018 or April 2018.
• If your inhaler matches, contact your pharmacy or provider for guidance.

Warning Signs of Defective Inhalers

• Lack of symptom relief: You notice no improvement after using the inhaler as prescribed.
• Unusual appearance: The inhaler’s outer wrapper appears bulged, puffed up, or abnormal.
• Early emptying: The device stops working before the indicated number of actuations.
• Weaker spray: The spray seems less forceful than usual.

If you detect any of these issues, stop using the inhaler and contact your healthcare professional.

FAQs: Ventolin Inhaler Recall

Q: Why were nearly 600,000 Ventolin inhalers recalled?

A: The devices were found to have a defect that may cause them to deliver fewer doses than indicated, due to a propellant leak. This defect was discovered after GSK received a higher-than-usual number of complaints about bulging wrappers, which signal a leak in the device’s mechanism.

Q: Is there a risk to patients who continue to use these inhalers?

A: There is a risk that patients may not receive an effective dose during an asthma attack or when experiencing other breathing difficulties, potentially leading to insufficient treatment. Immediate consulting with a healthcare provider is advised if the device seems ineffective.

Q: Should patients return their inhalers to the pharmacy?

A: This is not a consumer-level recall, so patients are not required to return inhalers they have already purchased. However, patients with affected inhalers are encouraged to contact GSK for more information and speak to their doctors about alternate medication if needed.

Q: What alternatives are available if my Ventolin inhaler is recalled?

A: Providers may prescribe a different batch of Ventolin HFA, a generic equivalent, or another appropriate rescue inhaler as needed. Discuss suitable options with your healthcare provider.

Q: Are other lots or brands of asthma inhalers affected?

A: As of this recall, only the three specific Ventolin HFA 200D lot numbers listed above are included. There have been no additional recalls extending to other batches or brands, but FDA advisories should be monitored for future updates.

What This Recall Means for Asthma Patients

Asthma control and patient safety depend on the reliable delivery of medication. Recalls of this nature remind patients and providers of the importance of:

• Regularly checking prescription lots and expiration dates
• Monitoring for unusual device performance or appearance
• Reporting product complaints to the manufacturer and FDA to enhance safety tracking
• Having backup medication accessible in case of device failure

If you are ever unsure about your inhaler’s effectiveness, seek guidance from your healthcare provider without delay.

Contact for Additional Information

Questions about the recall or defective products can be directed to GSK’s customer service center at 1-888-825-5249, or to your healthcare provider or local pharmacist.

Helpful Resources for Patients and Families

• Asthma and Allergy Foundation of America (AAFA):Offers guidance for people with asthma on managing medication recalls and drug shortages.
• FDA MedWatch:Provides updates on recalled medical products.
• Healthcare providers:For immediate advice, prescription refills, or medical support.

Key Takeaways

• GSK’s recall affects nearly 600,000 Ventolin HFA 200D inhalers with specific lot numbers, due to potential propellant leaks causing under-delivery of doses.
• The recall is limited to healthcare supply channels, but patients should check their inhalers for affected lot numbers and seek alternatives if necessary.
• Reliable access to rescue medication is critical for asthma and COPD management—contact your provider or pharmacist if your inhaler is not working effectively.
• Patients are reminded to report drug defects and remain vigilant about the medications they rely upon for their health.