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Cipla is recalling over 20,000 packs of Ibuterol Sulfate Inhalation Aerosol in the US
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The recall is due to failed stability specifications found in particle size distribution analysis
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The issue was detected at the 12-month time point during product stability testing
Drug major Cipla is recalling over 20,000 packs of a medication, used to treat asthma and certain types of chronic obstructive pulmonary disease, in the US, according to the US health regulator.
In its latest Enforcement Report, the US Food and Drug Administration stated that Cipla USA, Inc., an arm of the Mumbai-based drug major, is recalling Ibuterol Sulfate Inhalation Aerosol.
The company is recalling 20,352 packs of the inhalation drug due to 'Failed Stability Specifications', it stated.
'Out-of-specification results were observed in Induction Port during the analysis of Particle size distribution at the 12-month time point,' USFDA added.
Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases.
New Jersey-based Cipla USA, Inc. initiated the Class III recall on July 24 this year.
As per the USFDA, a Class III recall is initiated in a 'situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences'.
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