Cipla recalls inhalation drug in US over quality concerns
What's the story
Cipla, a leading Indian pharmaceutical company, has announced the recall of over 20,000 packs of its inhalation drug in the United States. The decision comes after the US Food and Drug Administration (FDA) flagged "Failed Stability Specifications" for the medication. The recalled drug is Albuterol Sulfate Inhalation Aerosol, which is commonly used to treat asthma and certain types of chronic obstructive pulmonary disease (COPD).
Recall details
What is the issue with the drug?
The USFDA's Enforcement Report revealed that Cipla USA, Inc., a subsidiary of the Mumbai-based company, is recalling 20,352 packs of Albuterol Sulfate Inhalation Aerosol. The FDA noted, "Out-of-specification results were observed in Induction Port during the analysis of Particle size distribution at the 12-month time point." This suggests potential issues with the drug's specifications over time.
Drug significance
Albuterol is a crucial medication
Albuterol, the drug in question, is a crucial medication for treating or preventing bronchospasm in patients suffering from asthma, bronchitis, emphysema, as well as other lung diseases. The recall of this important drug underscores the importance of maintaining drug quality standards.
Recall classification
Cipla USA initiated a Class III recall
Cipla USA, Inc. initiated a Class III recall on July 24 this year. According to the USFDA, a Class III recall is issued in cases where use or exposure to a violative product is not likely to cause adverse health consequences. This classification indicates that the use of the product is not expected to pose any immediate health risks to patients.