After the the top US medical watchdog, the Centers for Disease Control and Prevention (CDC), linked an eyedrop manufactured by the Tamil Nadu-based Global Pharma Healthcare to a highly drug-resistant bacteria, Tamil Nadu's drug regulator has said it found "no contamination" in samples of eye drops manufactured by the same.
The director of the Tamil Nadu Drugs Control PV Vijayalakshmi has said no contamination was found in samples from unopened eye drops manufactured by the Chennai plant.
According to the director, "Samples from several batches, including the one under question, were analysed. We found no contamination. The raw materials too were found as per standards,"
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What did the US health regulators say?
The Centers for Disease Control and Prevention (CDC), the top medical watchdog in the US, has linked the eyedrops to the likelihood of a highly drug-resistant bacteria gaining a foothold in the US.
Citing the Centers for Disease Control and Prevention (CDC), The New York Times earlier reported that three deaths, eight cases of blindness and dozens of infections had been traced to eyedrops made by Tamil Nadu-based Global Pharma Healthcare under the brand name EzriCare Artificial Tears.
Global Pharma recalls eye drop
Following this incident, Global Pharma Healthcare decided to recall 50,000 tubes of eye ointment in the US market due to bacterial contamination, according to the US Food and Drug Administration (USFDA).
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As per its latest Enforcement Report, the US health regulator noted that the Chennai-based drug firm is recalling the affected lot of "Artificial Eye Ointment" in the US market.
The lot has been manufactured by Chennai-based Global Pharma Healthcare and distributed in the US market by New York-based Delsam Pharma, the USFDA said.
Stating the reason for recall, the US health regulator said: "FDA analysis found unopened tubes to be contaminated with bacteria."
The company initiated the Class I recall on February 24 this year.
As per the USFDA, a Class I recall is the most urgent of the three types of FDA recalls and usually pertains to defective products that can cause serious health problems.
In a separate disclosure, the USFDA stated that Mumbai-based Sun Pharma is recalling 1,920 bottles of Dofetilide Capsules, which are used to treat irregular heartbeat.
The affected lot has been produced at Sun's Dadra-based plant, the USFDA stated.
The US-based unit of the company -- Sun Pharmaceutical Industries Inc -- is recalling the lot due to "Failed content uniformity specifications," it added.
The New Jersey-based firm initiated the Class III recall on March 9.
As per USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences."
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(With PTI Inputs)
