USFDA: Cipla and Glenmark withdraw medications from the US market

USFDA: Cipla and Glenmark withdraw medications from the US market

The impacted lot is being recalled by Cipla USA because of "short fill". According to the USFDA, there have been reports of reduced fill volume in respule and a few liquid droplets seen in the intact pouch.

With around 20% of the world market share, India is the leading producer of generic medications, producing 60,000 distinct generic products in 60 therapeutic areas.

The US health agency has announced that drug manufacturers Cipla and Glenmark are recalling goods from the American market because of manufacturing problems. According to the most recent Enforcement Report from the US Food and Drug Administration (USFDA), 59,244 packets of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are being recalled by a Cipla subsidiary situated in New Jersey.

The drug, which is made at the company's facilities in the Indore Special Economic Zone, is used to assist manage the symptoms of lung conditions including emphysema, chronic bronchitis, and asthma. The impacted lot is being recalled by Cipla USA because of "short fill". According to the USFDA, there have been reports of reduced fill volume in respule and a few liquid droplets seen in the intact pouch.

On March 26 of this year, Cipla started the Class II recall in the US market. Additionally, according to the USFDA, Glenmark Pharma is recalling 3,264 bottles of extended-release Diltiazem hydrochloride capsules, which are used to treat high blood pressure.

The drug is being recalled by the company's US division, Glenmark Pharmaceuticals Inc., USA, because of "failed dissolution specifications". On April 17, 2024, the business started the countrywide recall in the United States.

According to the USFDA, a class II recall is started when there is little chance of major adverse health effects from using or being exposed to a violative product, or when there may be transient or medically recoverable adverse health effects. With around 20% of the world market share, India is the leading producer of generic medications, producing 60,000 distinct generic products in 60 therapeutic areas.

Over 200 countries worldwide get the nation's produced goods, with the US, Japan, Australia, and Western Europe being the primary recipients. The largest number of USFDA-compliant businesses with overseas factories are located in India.