Strides Arcolab falls as much as 3.8 percent, but was last trading flat.
Strides' Italian unit Beltapharm SPA received an import alert on Monday, according to the U.S. FDA website. (1.usa.gov/1tg34DK)
Alert applies to skin care products, including Beneks Cleartone Fast Action Cream, Beneks Cleartone Fast Action Gel and Beneks Fashion Fair Cream.
Company, however, says its Italian unit has only one drug application approved for the U.S. market, Imiquimod cream, used to treat some skin diseases.
Adds the products mentioned by the U.S. FDA in its import alert are for an African customer.
Says it has no role in the distribution of those products in the United States.
"The Company is working with the U.S. FDA and the African customer on the circumstances of how these products reached the U.S. markets," Strides said in a filing to exchanges.
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(Reporting by Abhishek Vishnoi)