Cipla, Glenmark Recall Drugs From Market: USFDA

New Delhi: Drug makers Cipla and Glenmark are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.

The medication, produced at the company’s Indore SEZ plant, is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis and emphysema.

Cipla USA is recalling the affected lot due to “short fill”. There were complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, USFDA said.

Cipla initiated the Class II recall in the US market on March 26 this year.

USFDA also said that Glenmark Pharma is recalling 3,264 bottles of Diltiazem Hydrochloride extended-release capsules indicated for high blood pressure.

The US-based arm of the company — Glenmark Pharmaceuticals Inc USA — is recalling the medication due to “failed dissolution specifications”.

The company initiated the nationwide (US) recall on April 17, 2024.

As per USFDA, a class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

India is the largest supplier of generic medicines, with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, Western Europe and the US as the main destinations.

India has the highest number of USFDA-compliant companies with plants outside the US.

Related Posts

  • Pharma
  • May 25, 2024
  • 65 views
NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of asthma inhaler drug combination formoteral 6 mcg and budesonide 400 mcg dry power inhaler (DPI) under…

  • Pharma
  • May 25, 2024
  • 75 views
Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Jaipur: To provide quality education in pharmacy institutes, the central government has prepared to end the duplicate system. Strict action will be taken against fake students and teachers in newly opened…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

A Doctor diagnoses Mood of Voters in Delhi

A Doctor diagnoses Mood of Voters in Delhi

NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Tripura Police Seized Banned Cough Syrup Worth Rs 30 Lakh In Dhalai; One Arrested

Tripura Police Seized Banned Cough Syrup Worth Rs 30 Lakh In Dhalai; One Arrested

Ex-Pharmacy Council Registrar Gave Certificates To Ineligible Candidates?

Ex-Pharmacy Council Registrar Gave Certificates To Ineligible Candidates?

Experts Call For Ethical Standards, Patient Advocacy In Clinical Research

Experts Call For Ethical Standards, Patient Advocacy In Clinical Research