GlaxoSmithKline Initiates Recall of Nearly 600,000 Inhalers

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On April 4, pharmaceutical giant GlaxoSmithKline (GSK) announced a voluntary recall of approximately 593,000 prescription inhalers due to concerns regarding a potential defect in the device’s delivery system. This recall encompasses units retrieved from hospitals, pharmacies, and retailers across the United States.

The inhalers in question are Ventolin HFA 200D, as identified by the Asthma and Allergy Foundation of America. The specific lot numbers affected by this recall include: 6ZP98486, ZP00036, and ZP9944. It is important to note that this recall is not directed at consumers; however, individuals should verify if their inhalers fall within the affected batches.

According to a representative from GSK, the recall is a precautionary measure prompted by reports of the inhaler’s overwrap—the pouch that protects the inhaler—becoming inflated due to product leakage. This leakage poses a risk of delivering fewer doses than indicated on the inhaler’s counter. As a result, users may mistakenly believe they have more medication available than they actually do.

Patients are advised not to return their inhalers but should instead contact GSK’s response center if they have concerns regarding the effectiveness of their device. GSK issued a statement emphasizing that while the overall benefit-risk assessment for the Ventolin HFA 200D inhaler remains favorable when used as directed, there is a potential risk for patients experiencing reduced bronchodilation during acute bronchospasm if they depend on an inhaler that may not deliver the expected number of doses. GSK expressed regret for any inconvenience this situation may cause, reiterating their commitment to providing high-quality products and ensuring patient satisfaction.

It is crucial to note that the medication itself remains safe for use; the primary concern lies in users misjudging the amount of medication left due to the leakage. Pharmacies should still have adequate supplies of Ventolin HFA 200D inhalers for those requiring refills.

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In summary, GlaxoSmithKline’s recent recall of nearly 600,000 Ventolin HFA 200D inhalers was initiated due to a potential delivery system defect that could lead to inaccurate dosing. While the medication itself is safe, users should be aware of the risks associated with this issue and verify the lot numbers of their inhalers.


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