Johnson and Johnson’s baby powder license canceled by Maharashtra FDA, company asked to withdraw product

The decision was taken after the referral Central Drugs Laboratory in Kolkata agreed with the Maharashtra FDA’s report of 2019, declaring the product sub-standard.

Swapnil MishraUpdated: Friday, September 16, 2022, 11:41 PM IST
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The Maharashtra Food and Drug Administration (FDA) has cancelled the manufacturing licence of Johnson and Johnson’s baby powder for its Mulund plant and has asked the company to withdraw the product from the market.

The decision was taken after the referral Central Drugs Laboratory in Kolkata agreed with the Maharashtra FDA’s report of 2019, declaring the product sub-standard.

In 2019, the state FDA had checked the product samples from Pune and Nashik for quality and declared them ‘not of standard quality’ as per the government’s test pH guidelines for infants.

The FDA had issued a show cause notice to the firm under the Drugs and Cosmetics Act (1940) and Rules, asking why action such as suspension or cancellation of manufacturing licence should not be taken. It had also issued instructions to recall the product stock from the market.

However, the company did not accept the reports of the government analyst and challenged it in court, seeking to send the samples to the referral Central Drugs Laboratory in Kolkata.

Abhay Pandey, the president of All Food and Drugs Licence Holders Foundation said, “When I came to know about Johnson and Johnson baby powder sample failure, I immediately contacted the state FDA to take necessary steps in this matter as it’s one of the most selling baby powders in the market and incorrect pH can harm infants.”

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