Sun Pharma recalls its drug in the US

November 19, 2014 | Wednesday | News | By BioSpectrum Bureau

Sun Pharma recalls its drug in the US

The company is recalling the drug for failing dissolution specification

The company is recalling the drug for failing dissolution specification

Sun Pharma has decided to recall 68,194 bottles of its Venlafaxine Hydrochloride Extended-Release tablets, an anti-depression in the US. The company is recalling the drug for failing "dissolution specification". The 37.5 mg tablets in 30-count bottles and 90-count bottles, were manufactured by Sun Pharmaceutical Industries at Halol for Sun Pharma Global, Dubai.

The withdrawal was classified as a Class-II recall, which the FDA defines as 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.

 

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