In a significant move, the Maharashtra government’s Food and Drugs Administration agency cancelled the license of Johnson & Johnson Pvt Ltd to manufacture baby powder, one of its most popular products.
The order was issued by FDA, Maharashtra government, against Johnson & Johnson, Mulund.
The manufacturing licence was cancelled after samples of Johnson & Johnson’s baby powder, collected from Nashik and Pune failed quality checks.
The FDA has also ordered the company to recall its stocks from the market.
Among the reasons cited was that the powder may affect skin of newborn babies.
Samples of the powder for babies did not conform to standard pH value during laboratory tests, it said.
According to a press statement, the move was initiated after the Kolkata-based Central Drugs Laboratory's conclusive report that concludes that “the sample does not conform to IS 5339:2004 with respect to the test for pH."
The government analyst had declared the samples as "not of the standard quality" as they do not comply with IS 5339:2004 specification for skin powder for infants in the test pH, it said.
Thereafter, FDA issued a show-cause notice to Johnson and Johnson under the Drugs Cosmetics Act 1940 and Rules, besides issuing instructions to the company to recall the stock of the said product from market, said the release.
The firm "didn't accept the report" of the government analyst and challenged it in court for sending it to the Central Drugs Laboratory, it added.
Johnson & Johnson said in August it would stop selling talc-based baby powder globally in 2023, more than two years after it ended US sales of a product that drew thousands of consumer safety lawsuits.
Published 17 September 2022, 11:23 IST