Sun Pharma unit Taro Pharmaceutical Industries is recalling more than 17,000 units of an antifungal medication in the US over manufacturing lapses, according to the US drug regulator.
In its latest Enforcement Report, the USFDA said Sun Pharma/Taro, based in Hawthorne, is recalling 17,664 units of Ciclopirox Shampoo, an antifungal treatment commonly prescribed for seborrheic dermatitis, a condition that causes dry, flaky and itchy skin.
The company is recalling the affected lot due to “Failed Impurity/Degradation specifications,” the USFDA stated.
The company initiated the Class II nationwide recall on December 9 this year, PTI reported.
As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Sun Pharmaceutical Industries completed the merger of Taro Pharmaceutical Industries with itself in a deal valued at USD 347.73 million last year.
After the merger, Taro is now a private company and wholly owned by Sun Pharma.
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.
Read also: Taro Pharma now wholly owned by Sun Pharma