Global Pharma Healthcare is recalling 50,000 tubes of eye drops in the U.S. market due to bacterial contamination, according to the US Food and Drug Administration.
As per its latest Enforcement Report, the U.S. health regulator noted that the Chennai-based drug firm is recalling the affected lot of eye lubricant for artificial tears which have been linked to vision loss in the U.S.
The lot has been manufactured by Chennai-based Global Pharma Healthcare and distributed in the U.S. market by New York-based Delsam Pharma, the U.S. FDA said.
Stating the reason for recall, the U.S. health regulator said: "FDA analysis found unopened tubes to be contaminated with bacteria."
The company initiated the Class I recall on Feb. 24 this year.
As per the U.S. FDA, 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 February, Global Pharma Healthcare had announced that it is recalling its entire lot of eye drops allegedly linked to vision loss in the U.S.
Artificial Tears Lubricant eye drops are used as a protectant against irritation or to relieve dryness of the eye.
In a separate disclosure, the U.S. FDA 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 U.S. FDA stated.
The U.S.-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 U.S. FDA, 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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