Source: Pharmaceutical Technology
The recalls involve inhalation solutions and extended-release capsules used for treating respiratory conditions and high blood pressure, respectively.
This product is manufactured at Indore SEZ plant of the company in India.
Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
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.
The medication, intended for high blood pressure treatment, was recalled due to “failed dissolution specifications”.
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.