Cipla and Glenmark initiate recall of certain products in the US
06 May 2024
Drug Approval
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Source: Pharmaceutical Technology
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is prescribed for controlling the symptoms of lung diseases. Credit: mi_viri / Shutterstock.com.
Cipla and Glenmark Pharmaceuticals are recalling specific products from the US market due to distinct manufacturing issues, the latest Enforcement Report issued by the US Food and Drug Administration (USFDA) noted.
The recalls involve inhalation solutions and extended-release capsules used for treating respiratory conditions and high blood pressure, respectively.
New Jersey-based subsidiary of Cipla, Cipla USA is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.
This product is manufactured at Indore SEZ plant of the company in India.
It is prescribed for controlling the symptoms of lung diseases such as chronic bronchitis, asthma, and emphysema.
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The recall of the affected inhalation solution lot is claimed to be due to complaints of “short fill”.
The US regulator detailed that the affected lot was recalled after reports of less fill volume in respules and the presence of a few drops of liquid in the intact pouch.
Simultaneously, Glenmark Pharmaceuticals, USA, the US-based arm of Glenmark, announced the recall of 3,264 Diltiazem Hydrochloride extended-release capsules bottles.
The medication, intended for high blood pressure treatment, was recalled due to “failed dissolution specifications”.
In a related event last month, Glenmark’s US unit recalled 6,528 bottles of Diltiazem Hydrochloride extended-release capsules.
This Class II recall was due to the medication not meeting dissolution specifications, with “Out of Specification (OOS) results in a dissolution test at the 12-month time point during a long-term stability study.”
The affected lot was also produced in India.
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