India’s Cipla, Glenmark Recall Drugs In US

NEW DELHI,
Drug makers Cipla and Glenmark are recalling their products from the US market due to manufacturing issues.

Following the latest Enforcement Report from the US Food and Drug Administration (USFDA), Cipla’s subsidiary in New Jersey is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.

The reason for recalling the affected lot of Cipla products is “short fill.” FDA said, “Complaints received of less fill volume in repulse and few drops of liquid observed in the intact pouch.” This product is manufactured at the Indore SEZ plant of the company in India.

The recalled drug is used to help control the symptoms of lung diseases, including asthma, chronic bronchitis, and emphysema.

As mentioned by the USFDA, Glenmark is recalling 3,264 bottles of Diltiazem Hydrochloride extended-release capsules, which are used to treat high blood pressure.

The US-based arm of the company, Glenmark Pharmaceuticals initiated the nationwide recall of the drug due to “failed dissolution specifications.”