Re: The case of vanishing fungus from suspension !

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Hi, Cases of fungal contamination are even found in some IV pints and pediatric syrups. If they are macroscopic, we can catch them, but if microscopic and /or in amber coloured bottles, we don't notice it and simply rely on the expiry dates. Can anything more be done? That reminds me of my friend who had purchased a pack of cream biscuits of "X" brand.There was fungal contamination. A complaint along with the packet was sent to the company. The company accepted the fault and a month supply of biscuits were sent as compensation! Anupama. Vijay <drvijaythawani@...> wrote: Hi This is second contribution from our NetRUMian Rajendra Diwe. I have added some remarks, which are in red. Vijay ------------------------------------------------------------------------ - By Rajendra Diwe Pharmaceutical companies are playing with the lives of patients said Dilip Deshpande, General Secy of Maharashtra State Medical and Sales Representatives Association, quoting example of ZORONO, a

suspension marketed by FDC Limited. On July 6, 2007 a patient went to Ayushi Medical Stores, Sakkardara square, Nagpur, India and purchased a bottle of ZORONO, containing combination of Ofloxacin and Ornidazole (This is an irrational FDC of antimicrobial and antiamoebic. It is rare to find a patient simultaneously suffering from both types of dysenteries at the same time - Vijay). The suspension is used in Diarrhea (Absurd suggestion as diarrhea only requires ORS - Vijay), Dysentery or Gastro enteritis. A medical representative (MR) who was standing at the counter of the medical store saw fungus in that bottle and purchased two bottles which

were in stock, which also had fungus (batch XOP 7011, Mfd Date: Jan 2007, Exp. Date: Dec 2008). He took the photographs of the bottle and reported the matter to President of Nagpur District Druggist and Chemists Association and stockist of FDC Limited, who assured that the association will take care of it. Deshpande wrote a letter to General Secretary of Federation of Medical Representatives Association of India (FMRAI) regarding this on July 7, enclosing the photographs of the bottles having fungus. When The Hitavada probed, and contacted President of Nagpur District Druggist and Chemists Association, he denied the presence of any fungus in the ZORONO. He told that association has lodged a complaint to FDA which had collected the samples of the said suspension. On enquiry The Hitavada found that there was no stock of the said batch of ZORONO available in any pharmacy shop! The Drug Inspector, who was handling the case, told that four bottles of ZORONO were collected as sample having same batch no XOP 7011, Mfg Date January 2007 and Expiry Date Dec.2008, as a routine procedure. FDA had not received any complaint regarding fungus in that. FDA collected the samples from Abhyankar Aushadhi

Bhandar, the stockist of FDC limited. He also told that no fungus was there in the sample bottles. It may be recalled that fungus contaminated bottles were reported by MR on July 7 and FDA collected the samples on July 25, as informed by the stockist. Dilip Deshpande questions: Why such delay in collecting the samples? Where did the entire stock of the

medicine go from the market? Why the Chemists and Druggists Association did not make any attempt to inform the public about presence of fungus? How many bottles of the concerned batch were supplied by the company all over India? How many bottles were consumed by the children in India? The pharmaceutical experts opine that any product having moisture can develop fungus.

Suspension is no exception as it has water and binder gum, which are ideal for developing a fungus. If the proper preservatives are not added or if the storage conditions are improper, the fungus will grow. Fungus grows in pickles, jams, jellies etc. Except alcohol, fungus can be seen in every formulation. Fungi are known to cause hemorrhagic lung disease. Several infants in Cleveland, Ohio, US were found suffering from the disease. Some even die of complications of it. The exposed infants develop severe asthma and allergies.

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