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Drug major Cipla is recalling in the US market 1,40,625 vials of Levalbuterol Inhalation Solution used for relieving shortness of breath and coughing caused by asthma and chronic obstructive pulmonary disease.
As per the information available on the USFDA website, Cipla is recalling the drug for "failed impurities and degradation specifications".
The vials were manufactured by Cipla at its Pithampur manufacturing facility, near Indore, for Princeton-based Dr Reddy's Laboratories Inc, it added.
The nationwide recall has been initiated by the company on April 24 this year.
The recall of the drugs has been initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
A query sent to a company spokesperson remained unanswered.
Cipla, which has presence in over 150 countries, sells more than 2,000 products across various therapeutic categories.
The company has 34 manufacturing facilities that make active pharmaceutical ingredients (APIs) and formulations.
Cipla shares were trading at Rs 674.50 apiece on the BSE, down 1.97% from their previous close.
