Indian pharmaceutical companies Cipla and Glenmark are recalling certain products from the American market due to manufacturing issues, according to the US health regulator.
Cipla's New Jersey-based subsidiary is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. The medication, produced at Cipla's Indore SEZ plant, is used to help control symptoms of lung diseases like asthma, chronic bronchitis, and emphysema.
The recall by Cipla USA is due to "short fill," with complaints of less fill volume in the respule and a few drops of liquid observed in the intact pouch, as stated by the USFDA. The Class II recall was initiated on March 26 this year.
Glenmark Pharma is also 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, initiated the recall due to "failed dissolution specifications" on April 17, 2024.
According to the USFDA, a Class II recall is initiated when the use of a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
India, being the largest supplier of generic medicines, manufactures around 60,000 different generic brands across 60 therapeutic categories. Products manufactured in India are shipped to over 200 countries globally, with Japan, Australia, Western Europe, and the US being the main destinations. India boasts the highest number of USFDA-compliant companies with plants outside the US.