Immediately suspend use of Magnex, Magnex Forte, Zosyn, Magnamycin: Pfizer warns doctors, chemists against use of 4 antibiotics
New Delhi: Citing an alert on "deviation in manufacturing process", drug major Pfizer has initiated temporary suspension of the sale and use of its life-saving antibiotic Magnex, Magnex Forte, Zosyn and Magnamycin in India with immediate effect.
The antibiotics, Magnex, Magnex Forte, Magnamycin and Zosyn, are all prescribed to treat various types of bacterial infections and can be used only under medical observation.
In a letter written to stockists, distributors and hospitals issued on May 16, Pfizer said, “You are requested not to undertake any further sale, distribution of the products for all stock-keeping units (SKUs) in your possession, with immediate effect, till further notice from Pfizer.’’
The company said the decision was taken due to some “deviations” at the manufacturing facility of the flagged drugs. The letter further identified the manufacturer as ‘Astral Steritech Private Limited’. The company was informed by its contract manufacturer in India, Astral, that it has observed an out-of-specification during a routine environmental monitoring of its manufacturing block.
“Whilst the manufacturer is currently investigating the matter, they have requested Pfizer, as an abundant precautionary measure and as per best practices, to temporarily suspend the sale/distribution/supply and use of the aforementioned products, pending the investigation by the manufacturers…” the pharma major said in a statement.
However, Pfizer assured that all reasonable efforts are being taken to resolve the matter.
“We will keep you informed on the investigation and further steps to be taken in this regard,” Pfizer added.
Meanwhile, the All-India Organization of Chemists and Druggists (AIOCD) swung into action to alert chemists across the country and has written to its state units to suspend the sale, distribution and supply of these products immediately.
"In light of these observations, it is imperative that you immediately inform all trade and hospital stakeholders in your respective states and districts to temporarily suspend the sale, distribution, supply, and do not use of the aforementioned products till further notice," Rajiv Singhal, general secretary, AIOCD, said in a letter.
To elaborate, Magnex is prescribed to treat different types of bacterial infection; Zosyn is used to treat many different infections caused by bacteria, such as stomach infections, skin infections, pneumonia, and severe uterine infections.
Both Magnamycin injections and Magnex Forte are also used to treat bacterial infections such as ear, sinus, throat, lung, urinary tract, skin and soft tissues.
In a regulatory filing, the company said it has decided to initiate a voluntary recall of Magnex (1gm, 2gm), Magnex Forte (1.5gm, 3gm), Zosyn (4.5gm) and Magnamycin (250mg, 1gm, 2gm).
Though the company mentioned that the decision is likely to have an impact on the revenue and profitability of the company, it said that it places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.
The said products recorded a sale of Rs 139 crore for the year ended on March 31, 2023, Pfizer told PTI.
