Cadila Pharmaceuticals – an industry leader in synthesizing APIs has initiated a recall of Ondansetron HCI API supplied to LLC LENS Phanna in Russia, Claris Irljectable in Ahmedabad and CPL. Inc in USA.
The Voluntary: Firm Initiated recall is for 6 kilo’s of Ondansetron HCI API and has been classified as a Class II Recall – 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.
The reason for recall mentioned by Cadila Pharmaceuticals was due to the Microbial Contamination of Non-Sterile Product – microbial contamination can reduce or even eliminate the therapeutic effect of drugs or cause drug-induced infections. Microbes presented in drugs not only makes them hazardous from the infectious standpoint, in addition may change the chemical, physical and organoleptic properties of the drugs or change the contents of active ingredients. Furthermore, microorganisms can convert drugs to toxic products.
The batch contaminated was from supplied from batch 150N004 with an expiry of 08/20 and batch 150N006 with an expiry of 09/20.
What is Ondansetron HCL?
Ondansetron HCL is used alone or with combination of other medications to prevent nausea and vomiting caused by chemotherapy or radiation therapy. It is sometimes also used to stop and treat nausea and vomiting after surgery is done. It blocks one of the body’s natural substances named serotonin, which is responsible for cause of vomiting.
Cadila supplies nausea and vomiting drug Ondansetron HCL to the North American countries like; USA, Canada, Mexico, Cuba, etc.