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India: Maharashtra FDA cancelled Johnson & Johnson Licence of Manufacturing Baby Powder Poor quality

The state Food & Drug Administration (FDA) cancelled the company's license to manufacture the baby powder, ordered a recall and served it a show-cause notice.

More than a month after Johnson & Johnson announced that it will stop the sale of its talc-based baby powder globally in 2023, the Indian state of Maharashtra on Friday cancelled the manufacturing license of the pharmaceutical company.

Reportedly, the state's Food & Drug Administration (FDA) cancelled the company's license to manufacture the baby powder citing an inspection where it found its premier baby product to be sub-standard in quality.

The agency collected samples from Pune and Nashik for quality checks and found the pH value of the powder to be much higher than the permissible levels.

Consequently, the US-based company was issued a show-cause notice and ordered to recall all its stocks as the use of the product could affect the health and skin of newborn babies, according to an FDA statement.

Johnson & Johnson, however, refused to accept the FDA's report and informed that it will challenge it in court. moreover, the company argued that the sample be sent to the referral laboratory i.e Central Drugs Laboratory Govt., of India, Kolkata.

J&J and its controversial product

As reported extensively by WION, in August, J&J announced that it will be discontinuing the sales of its controversial talc-based baby powder globally in 2023.

"As part of a worldwide portfolio assessment, we have made the commercial decision to transition to an all cornstarch-based baby powder portfolio. As a result of this transition, talc-based J&J Baby Powder will be discontinued globally in 2023," read the company's statement.

The announcement to cease the product sales globally came two years after J&J halted its sales in USA and Canada.

For years, J&J talcum powders, especially baby powders have been at the centre of controversy. Over 38,000 lawsuits have been filed by the consumers as well as the survivors, some of whom allege they were hurt by the use of the product. Some of the lawsuits claim the powder contained cancer-causing material like asbestos.

However, despite the mountain of allegations and the termination of talc-based powder sales, J&J continues to claim that its product is safe and perfectly fit for health.

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