Aurobindo and Sun Pharma recall products from US

Aurobindo Pharma and Sun Pharma are recalling different products in the US market due to deviation from standard manufacturing norms.

According to the latest enforcement report issued by the US Food and Drug Administration (FDA), the US-based arm of Aurobindo Pharma is recalling 1,15,776 bottles of Moxifloxacin Ophthalmic Solution, an antibiotic used in the treatment of bacterial infections.

According to FDA, the Princeton-based Aurobindo Pharma USA Inc is recalling the affected lot due to “failed impurities/degradation specifications.”

The company initiated the nationwide class-II recall on 14th January this year.

The FDA said the US-based arm of Sun Pharma is recalling 59,232 bottles of Chlorthalidone tablets, used for reducing excess fluid levels in the body.

As per the US health regulator, the New Jersey-based Sun Pharma Inc is recalling the affected lot due to “foreign matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup.”

The company initiated the class-II voluntary recall on 7th February, 2022.

As per the FDA, a class-II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Edits by EP News Bureau