Maharashtra FDA has asked Johnson & Johnson to recall the products of the faulty batch from the market. But as per reports, J&J "didn't accept the report" of the government analyst and challenged it in court for sending it to the Central Drugs Laboratory.
Maharashtra FDA has cancelled the license of Johnson & Johnson baby powder and has stopped the manufacturing and selling of the product in the state after it found that the powder for infants has a pH value above the mandated limit.
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"We have issued a show cause notice to the company asking them to explain why their license shouldn't be cancelled," Maharashtra FDA sources told CNBC-TV18.
The FDA had collected two samples of the Johnson & Johnson baby powder — one from Pune and the other from Nashik — and the test results stated it did not comply with the IS5339:2004 (second revision amendment 3) specification for skin powder for infants in the test pH.
The FDA has told the company to recall the products of the faulty batch from the market. But as per reports, the firm "didn't accept the report" of the government analyst and challenged it in court for sending it to the Central Drugs Laboratory.
Last month, Johnson & Johnson said it would stop selling talc-based baby powder globally in 2023 and move to a cornstarch-based baby powder portfolio. The decision occurred two years after it ended sales in the US and Canada due to safety lawsuits and falling demand.
"As part of a worldwide portfolio assessment, we have made the commercial decision to transition to an all cornstarch-based baby powder portfolio," J&J had said in a press release.
"We continuously evaluate and optimise our portfolio to best position the business for long-term growth. This transition will help simplify our product offerings, deliver sustainable innovation, and meet the needs of our consumers, customers and evolving global trends," the statement added.
It had said that its cornstarch-based baby powder is already sold in many nations.
First Published: IST