The drug makers Cipla and Glenmark are recalling products from the American market due to manufacturing issues, according to the US Health Regulator.
According to the latest enforcement report issued by the US FDA (US Food and Drug Administration), Cipla, a New Jersey-based subsidiary, is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.
The medication is manufactured at the company's Indore SEZ plant. It is used to control the symptoms of lung diseases such as emphysema, asthma, and chronic bronchitis. The US FDA said that Cipla USA is recalling the affected lot due to a short fill, and there were complaints of less volume in the response and a few drops of liquid observed in the intact pouch.
On March 26 this year, Cipla commenced the Class II recall in the US market. The US FDA also said that Glenmark Pharma is recalling 3,264 bottles of Diltiazem Hydrochloride extended capsules indicated for high blood pressure.
Glenmark Pharmaceuticals Inc., USA, the US-based arm of the company, is recalling the medication due to failed dissolution specifications. On April 17, this year, the company commenced the nationwide (US) recall. According to the US FDA, 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 unfavorable health consequences or where the possibility of serious adverse health consequences is remote.
India is the biggest distributor of generic medicines with approximately 20% share in the global supply by producing 60,000 different generic brands across 60 therapeutic categories.
The products that are manufactured in India are shipped to over 200 countries around the globe, and the major destinations are Japan, the US, Australia, and Western Europe. India has the highest number of US FDA-compliant companies with plants located outside the US.
(Input from various media sources)
(Rehash/Lavanya Beeraboina/SB)
