The Ciclopirox Shampoo -- an antifungal medication that treats seborrheic dermatitis (a condition that causes dry, flaky, and itchy skin) -- is being recalled due to “failed impurity/degradation specifications”, the USFDA said, in its latest Enforcement Report.
The Class II nationwide recall of 17,664 units of the Ciclopirox Shampoo was initiated by the company on December 9.
The USFDA defines a Class-II recall as a violative product whose use, or exposure to, may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Taro is a private company and wholly owned by Sun Pharma. The Israel-based company was acquired by Sun Pharma in a deal valued at 7.73 million last year.
Sun Pharma has been the majority shareholder of Taro since 2010.
Primarily focused on dermatology, Taro produces a wide range of prescription and over-the-counter products.
Indian pharmaceutical companies supply a substantial proportion of drugs to US residents, with four out of ten of all prescriptions filled in the US in 2022 being supplied by Indian companies.
Sun Pharmaceutical Industries is India’s largest formulation player by market share. The pharma giant is also a lead exporter to the US market, with revenue of Rs 14,478 crore in the second quarter of FY26.
While the drug major's net profit rose 2.56 per cent year-on-year to Rs 3,118 crore, formulation sales in the US declined 4.1 per cent to $496 million.
The weakness in its generics business was offset by growth in innovative medicines, according to the company.
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