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Dr Reddy's Laboratories, Cipla arm recall drugs from American market

The USFDA has classified both the recalls as a Class-II recall

Press Trust of India  |  New Delhi 

Pharmaceuticals, drugs, pharma industry, medical, health, lab

Drug Dr Reddy's Laboratories is recalling 33,958 bottles of Sodium Extended-Release tablets, used to treat seizure disorders, from the American market, as per a report by the US health regulator.

Besides, InvaGen Pharmaceuticals Inc, a subsidiary of Mumbai-based Cipla, is recalling over 7.8 lakh vials of Testosterone Cypionate injection, used to treat low testosterone levels in men.

Dr Reddy's Laboratories Inc, a subsidiary of the Hyderabad-based Dr Reddy's Laboratories, is voluntarily recalling the affected lot of bottles on account of certain deviations from the Current Good Manufacturing Practice (CGMP) regulations.

As per the latest enforcement report by the (USFDA), the firm is recalling the product as it has been exposed to above 50 per cent relative humidity levels during packaging operations.

The product was supplied to distributors and retailers who may have further distributed the product throughout the US, the report added.

Meanwhile, is recalling its product in various strengths due to the "presence of particulate matter", the report said.

The vials were manufactured by Cipla at its in for Cipla USA Inc.

The has classified both the recalls as a recall, which is initiated in a "situation in which use of or exposure to a may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First Published: Sun, April 28 2019. 12:50 IST
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