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  • Cipla recalls over...

Cipla recalls over 20000 packs of inhalation drug in US

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-08-28T13:15:42+05:30  |  Updated On 28 Aug 2025 1:15 PM IST
Cipla Bommasandra facility gets VAI classification from USFDA
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New Delhi: Pharmaceutical giant Cipla is recalling more than 20,000 packs of an asthma medication in the U.S. market, according to the U.S. Food and Drug Administration (USFDA).

In its Enforcement Report, the USFDA disclosed that Cipla USA, Inc., the subsidiary of the Mumbai-headquartered company, is recalling 20,352 packs of Ibuterol Sulfate Inhalation Aerosol, a drug prescribed for treating asthma and certain types of chronic obstructive pulmonary disease (COPD).

The company is recalling 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.
As per PTI, 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".
Read also: Cipla Secures CDSCO Panel Nod to Manufacture Amantadine Oral Solution with Trial Waiver

Medical Dialogues team had earlier reported that US-based arm of Cipla recalled 1,875 boxes of Lanthanum Carbonate chewable tablets (1000 mg, 10-count bottle) in the American market due to complaints of broken tablets.

Read also: Cipla Recalls Lanthanum Carbonate Tablets in US

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. The company strengths lies in the respiratory, anti-retroviral, urology, cardiology, antiinfective and CNS segments. Cipla 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 74+ markets.

Read also: CDSCO Panel Clears Cipla's Glycopyrronium-Formoterol Inhaler for Phase IV Trial

ciplacipla newsrecallasthmachronic obstructive pulmonary diseaseIbuterol Sulfate Inhalation Aerosol
Source : with inputs
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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