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, it added.
“While this issue is presently being investigated, out of an abundance of caution, Pfizer has decided to voluntarily recall from the market, all batches of these three products,” Pfizer Ltd said.
The drug maker is taking all necessary steps to resolve the situation, it added.
The above voluntary recall is likely to have an impact on the revenue and profitability of the company, it stated.
The said products recorded a sale of Rs 139 crore for the year ended on March 31, 2023, Pfizer said.
Astral manufactures three products for Pfizer, namely, Magnex, Magnamycin and Zosyn, and were marketed and distributed by Pfizer Ltd. Pfizer said it places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.
In a separate statement, the All India Organisation of Chemists and Druggists wrote to their members to temporarily suspend the sale of the three products.
“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,” it stated.