NEW DELHI — Leading drug makers Sun Pharma and Lupin are recalling products in the US, the world’s largest market for medicines, for different reasons.
As per the latest enforcement report by the US Food and Drug Administration (USFDA), Sun Pharma is recalling 696 bottles of Pregabalin capsules (50 mg), used for the treatment of epilepsy, anxiety, and nerve pain, in the US market.
According to the US health regulator, the Mumbai-based drug major is recalling the affected lot due to “failed tablet/capsule specifications: out of specification results for particle size distribution and bulk density of the active pharmaceutical ingredient.”
New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the company, initiated Class II nationwide (US) recall of the affected lot on October 22 last year.
As per the USFDA, 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.
Lupin, on the other hand, is recalling 50,832 bottles of Gatifloxacin Ophthalmic Solution, an antibiotic used to treat bacterial infections of the eyes.
As per the USFDA, the company’s US-based unit is recalling the affected lot due to “failed stability specifications: out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.”
The affected lot has been manufactured at Lupin’s Pithampur-based plant in Madhya Pradesh. The lot has been distributed in the US by Baltimore-based Lupin Pharmaceuticals Inc, the report stated.
The drug maker initiated Class III voluntary recall in the US and Puerto Rico on December 22 last year.
Lupin is also recalling 23,965 bottles of Oxycodone Hydrochloride tablets, used for the treatment of moderate to severe pain.
As per the USFDA, the company is recalling the lot due to “out-of-specification impurity test result observed at 18-month long term stability time point.”
The company’s US-based subsidiary initiated Class III recall on December 29 last year.
A Class III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.
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