Monday, December 4, 2023

Maharashtra: J&J loses licence to manufacture baby powder over quality issues

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After discovering that Johnson & Johnson baby powder has a pH value higher than the permitted limit, Maharashtra FDA revoked the company’s licence and suspended the manufacturing and sale of the product in the state.

According to Maharashtra FDA sources who spoke to the media, “We have issued a show cause notice to the company requesting them to explain why their licence shouldn’t be withdrawn.”

The FDA obtained two Johnson & Johnson baby powder samples, one from Pune and the other from Nashik. The results of the test revealed that the Johnson & Johnson baby powder did not meet the IS5339:2004 (second revision amendment 3) specification for skin powder for infants in the test pH.

The FDA has instructed the business to remove the flawed batch’s products from the market.

Johnson & Johnson announced last month that it would switch to a cornstarch-based baby powder portfolio in 2023 and discontinue selling talc-based baby powder on a global scale. The choice was made more than two years after sales were discontinued in the US and Canada as a result of safety litigation and declining demand.

According to a press release from J&J, “as part of a global portfolio assessment, we have made the commercial decision to migrate to an all cornstarch-based baby powder portfolio.”

“We continually assess and improve our portfolio to place the company in the best possible position for long-term success. As a result of this change, our product offerings will be made simpler, sustainable innovation will be delivered, and our customers’ and consumers’ needs as well as changing worldwide trends will be met “the sentence included.

It had claimed that numerous countries already sold its infant powder made of cornstarch.

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