Maharashtra FDA cancels manufacturing licence of Johnson’s Baby Powder

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The Food and Drugs Administration (FDA), Maharashtra said that it has taken action against Johnson's Baby Powder. An official statement released by the FDA Maharashtra said that it has cancelled the product manufacturing licence of Johnson's Baby Powder.

FDA Assistant Commissioner Ganesh Rokade said, "We had collected two samples from Nagpur and Pune between 2022-21. During our quality check process, the samples were not found to be of standard quality. The firm did not accept the report and had challenged the testing analysis in court for sending to the referral laboratory i.e Central Drugs Laboratory Govt., of India, Kolkata. The Director CDL, Kolkata confirms the report of Govt., Analyst, FDA Maharashtra and issued a final conclusive report stating the conclusion that 'The sample does not comply to IS5339: 2004 with respect to the test for pH'. As a result, we have issued instructions to recall the stock of the said product from the market."

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The official release further said, the FDA issued a show cause notice to the firm under Drugs and Cosmetics Act, 1940. It rules, as to why the action like suspension or cancellation of manufacturing licence or product manufacturing licence should not be taken. Also instructions have been issued to recall the stock of the said product from the market.

It further said, "The firm did not accept the reports of Govt. Analyst and challenged it in the court for sending to the referral laboratory i.e Central Drugs Laboratory Govt. of India, Kolkata. The Director CDL, Kolkata confirms the report of Govt. Analyst, FDA Maharashtra and issued a final conclusive report stating the conclusion that, 'the sample does not conform to IS5339 : 2004 with respect to the test for pH'. The product, Johnson's Baby Powder is popularly used in new born babies. The sample declared not of standard in pH and the use of the product may affect the health of the skin of the new born babies. Hence in the interest of the public health at large the FDA has cancelled the manufacturing licence of the Johnson's Baby Powder of M/s Johnson & Johnson Pvt. Ltd. Mulund, Mumbai vide order dated 15/09/2022."

Clarification: A previous version of this article had carried a statement by Johnson & Johnson sourced from agencies. That statement has been removed at Johnson & Johnson's request. The copy will be updated if and when Johnson & Johnson issues a fresh statement to us.