Dr Reddy’s Laboratories problem with ensuring products reach the market at a quality the FDA deems acceptable is no secret and, unfortunately for the company, it has once again been slapped with a recall of over 80,000 bottles of Atorvastatin.

Only last month, it was forced to recall more than 1,000 Docetaxel injection vials used to treat breast cancer and was also hit by a fine for improperly packaging its products.

Prior to this, in October of last year, it had received a recall notice to the tune of over half a million heartburn tablets and there are numerous cases beyond this.

Of course, with a generics company that produces as many medicines as Dr Reddy’s does, it is inevitable that there will be some quality issues – as all pharma companies face the occasional hiccup.

In this particular instance, the recall relates to Atorvastatin Calcium Tablets 10mg, 20mg and 40mg – a drug that lowers cholesterol.

According to the FDA, the recall was issued due to: "Failed Impurities/Degradations specifications; out-of-specification results observed for Total Degradation Impurities during stability."

The letter continued, "Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification (Class I, II or III) indicating the hazard posed by the recalled product(s)".

The product is produced by Dr Reddy’s plant in Srikakulam, Andhra Pradesh, India. The facility had only just cleared an FDA audit last month, with the company’s stock bouncing 4.67% on the news alone.

The company will have to wait on the hazard assessment to determine how serious the issue is, it has faced a number of run-ins with the FDA beyond simple recalls. A Notable example includes when FDA inspectors, in March 2017, caught lab employees deleting computers and recent documents relevant to the inspection.

Ben Hargreaves

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