Sun Pharma recalls 24,000 pre-filled syringes in US market

8 May 2023 , 08:30 AM

According to the USFDA, Sun Pharmaceutical Industries, a major pharmaceutical company, is recalling pre-filled syringes of a medication used to treat female infertility from the US market due to a manufacturing issue. 

The US Food and Drug Administration (USFDA) reported in its most recent Enforcement Report that the Mumbai-based drug giant is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection.

Due to the presence of particle matter, the company is recalling the impacted lot, according to the USFDA.

‘A piece of glass was found in a prefilled syringe,’ it continued.

Ferring Pharmaceuticals Inc. of New Jersey distributed the medicine in the US market on behalf of Sun Pharma, which produced it. According to USFDA, the corporation started the nationwide (US) recall on April 19.

16,450 vials of norepinephrine bitartrate injection had already been recalled by the company’s subsidiary Sun Pharmaceutical Inc. of New Jersey due to ‘failed impurities/degradation specifications.’

The pharmaceutical is also voluntarily withdrawing more than 34,000 bottles of a generic drug used to treat high blood pressure from the US market, according to the USFDA, because dissolving testing was unsuccessful.

The pharmaceutical sector in India ranks third globally in terms of volume and fourteenth globally in terms of value. In the fiscal year 2021–2022, India exported medicines worth Rs1,75,040 crore, comprising bulk medications and pharmacological intermediates.

The biggest market for pharmaceutical goods worldwide is the US.

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