Chennai-based Global Pharma recalls 50,000 tubes of contaminated eye drops in US: Report

Chennai-based drug firm Global Pharma Healthcare is said to be recalling 50,000 tubes of eye drops in the US market due to bacterial contamination, as per the US Food and Drug Administration (USFDA).

As per its latest Enforcement Report, the US 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 US, said a PTI report.

The USFDA stated that the lot has been manufactured by Chennai-based Global Pharma Healthcare and distributed in the US market by New York-based Delsam Pharma.

The US health regulator also mentioned the reason for the recall and said "FDA analysis found unopened tubes to be contaminated with bacteria."

Global Pharma Healthcare reportedly initiated the Class I recall on February 24, 2023. As per the US health regulator, 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 announced that it is recalling its entire lot of eye drops allegedly linked to vision loss in the US. Back here, the Central Drugs Standard Control Organisation and Tamil Nadu's Drug Controller had earlier conducted a raid on the company after US authorities flagged a possible contamination in a line of eye drops, sources told India Today.

Artificial tears lubricant eye drops are used as a protectant against irritation or to relieve dryness of the eye.

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 an 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."

(With PTI inputs)

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