Sun Pharma and Lupine recall products in the US market

Major drugmakers Sun Pharma and Lupin are recalling products in the United States, the world’s largest drug market, for different reasons.

According to the latest US Food and Drug Administration (USFDA) law enforcement report, Sun Pharma is recalling 696 bottles of pregabalin capsules (50mg), used for the treatment of epilepsy, anxiety and nerve pain, in the US market.

According to the US health regulator, the Mumbai-based pharmaceutical company is recalling the affected lot due to “tablet/capsule specification failure: out-of-specification results for particle size distribution and density appearance of the active pharmaceutical ingredient”.

New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the company, initiated the nationwide (US) Class II recall of the affected lot on October 22 last year.

According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to an offending product may result in temporary or medically reversible adverse health consequences or when the likelihood of serious adverse health consequences health is low.

Lupine, meanwhile, is recalling 50,832 bottles of gatifloxacin ophthalmic solution, an antibiotic used to treat bacterial eye infections.

According to the USFDA, the company’s US-based unit is recalling the affected lot due to “out of specification stability: out-of-specification results observed during a water loss test that could affect the contents of the dosing and modifying the concentration of the drug”.

The affected lot was manufactured at the Lupin factory in Pithampur, Madhya Pradesh. The batch was distributed in the United States by Baltimore-based Lupine Pharmaceuticals Inc, according to the report.

The drugmaker launched a voluntary Class III recall in the United States and Puerto Rico on December 22 last year.

Lupine is also recalling 23,965 bottles of oxycodone hydrochloride tablets, used for the treatment of moderate to severe pain.

According to the USFDA, the company is recalling the lot due to the “out-of-specification impurity test result observed at an 18-month long-term stability time point.”

The company’s US subsidiary launched a Class III recall on December 29 last year.

A Class III recall is initiated in a “situation in which use of or exposure to an infringing product is not likely to result in adverse health consequences”.

The US generic drug market was estimated at around $115.2 billion in 2019. It is the largest pharmaceutical market.

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