US-based units of Indian pharmaceutical companies, Unichem Laboratories and Aurobindo Pharma, have ordered a nationwide recall of different products in the regional market, citing manufacturing issues.
As per sources, Aurobindo Pharma USA Inc. has recalled 7,296 containers of its hypertension drug tablets, Carvedilol, following the recently issued enforcement report by the US Food and Drug Administration (USFDA).
Carvedilol, a beta-blocker, is used in the treatment of high blood pressure to prevent the chances of stroke, heart attack, or kidney problems.
The affected lot of 6.25 mg of Carvedilol tablets were produced in India and distributed by the Princeton-based unit, with the US health regulator reporting that reason for the recall is due to failed impurities and/or degradation specifications.
Aurobindo had, though, initiated the recall on November 15, the report added.
Similarly, Unichem Pharmaceuticals (USA) Inc. will be recalling 1,284 bottles of its Topiramate tablets, that were manufactured at Unichem’s Ghaziabad plant and distributed by its New Jersey-based unit.
Topiramate is used in preventing migraines and treating epilepsy, such as the treatment of Lennox-Gastaut syndrome, a rare and severe form of epilepsy that develops in early childhood.
The USFDA has noted that the product recall, which was initiated on October 25, has been undertaken voluntarily by the company due to discoloration in the affected lot.
Both of these recalls have been classified as Class III by the USFDA, which is initiated in a situation where using or being exposed to such a violative product will not likely cause any adverse health consequence.
Previously in October, Aurobindo Pharma had recalled 2,820 bottles of its metoprolol tartrate tablets due to the presence of foreign substance. Metoprolol, a hypertension drug used in the treatment of high blood pressure, was subject to complaint of metal wire being found in one tablet.