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Sun Pharma recalls batches of anti-migraine drug, testosterone injection in US


India’s largest drugmaker Sun Pharmaceutical Industries has recalled multiple batches of its anti-migraine drug sumatriptan succinate as well as testosterone cypionate for injection in the US, data on US Food and Drug Administration (FDA) website released Wednesday showed.

While the firm recalled sumatriptan succinate from the world’s largest pharmaceutical market due to presence of impurities in the medicine, batches of testosterone cypionate were recalled due to deviations from good manufacturing practice norms at the facility where it was made.

The recall of sumatriptan succinate was started last month, while that of testosterone cypionate was initiated last week, as per US FDA data.

Testosterone cypionate, used to treat low testosterone levels in men and in hormone therapy for transgender men, was manufactured by Sun Pharma at one of the company’s plants in Gujarat.

The company has recalled 207,585 blisters and another 384 bottles of 100 sumatriptan succinate tablets each in the voluntary class II recall, the data showed. Testosterone cypionate was also a class II recall.

A recall is designated class II if exposure to a product may cause temporary or medically-reversible adverse health consequences.

Sun Pharmaceutical’s reply to emailed queries on the recalls is awaited.

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