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Dear Readers, Welcome to the latest issue of Micro
India’s major drug making organization Lupin has recalled their various drugs from the US market because of multiple reasons. Sun Pharma & Glenmark Pharmaceuticals have also recalled their products from the US market. According to the current Enforcement Report which was issued by the USFDA, Lupin is recalling 55,000 vials & 1,60,241 boxed of anti-bacterial drug Ceftriaxone for injection in various strengths.
Lupin Pharmaceuticals, Inc which is the subsidiary of the Mumbai based firm has recall thereproducts which has been manufactured at the company’s facility which is based in Mandideep, Madhya Pradesh.
USFDA said, “There was a complained received of grey flecks, which was identified as shredded rubber particulate matter from the stopper observed in the reconstituted vials”
The current going on voluntary nationwide has been classified as Class-l, as such recalls are for dangerous and defective products which may cause serious health issues, whereas Lupin has also recalling 2,87,784 bottles of Cefdinir for Oral Suspension, which are used for treatment of the bacterial infections, for CGMP (Current Good Manufacturing Practice) deviations..
The current going on voluntary nationwide has been classified as Class-l, as such recalls are for dangerous and defective products which may cause serious health issues, whereas Lupin has also recalling 2,87,784 bottles of Cefdinir for Oral Suspension, which are used for treatment of the bacterial infections, for CGMP (Current Good Manufacturing Practice) deviations.
This has been classified as a Class-ll recall, which defines as “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 the serious adverse health consequences is remote”.
In the same way, Sun Pharmaceutical Industries is voluntarily recalling 13, 918 cartons & 1,39,180 vials of Vecuromium Bromide for Injection, used as part of general anaesthesia, sue to the presence of particulate matter.
Beside to this, Glenmark Pharmaceuticals is recalling 96,240 applicators of their products Estradiol Vaginal Inserts due to defective delivery system. The USFDA has termed it as a Class-ll recall.
