Lupin, Sun Pharma recall products in US
New Delhi: Leading drugmakers 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.
Read also: Lupin recalls cartons of oral contraceptive drug Tydemy in US
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