Washington, Dec 26: India-based pharmaceutical company Sun Pharma has suffered a major setback in the international market, with around 17,000 anti-fungal shampoos of its Sun Pharma subsidiary being recalled from the US market.
The US Food and Drug Administration (USFDA) has informed that the Sun Pharma subsidiary is recalling over 17,000 units of antifungal shampoos from the US market.
Taro Pharmaceutical Industries, a unit of Sun Pharma, is recalling over 17,000 units of antifungal medicines in the US due to manufacturing issues, the USFDA said.
According to its latest enforcement report, the US health regulator said that Hawthorne-based Sun Pharma/Taro is recalling 17,664 units of ciclopirox shampoo. It is an antifungal medication used to treat seborrheic dermatitis. It is said to cause dry and itchy skin.
The company is recalling the affected lot due to “impurities/deteriorated specifications”. The company initiated the Class II nationwide recall on December 9 this year, the USFDA said.
What is the process?
According to the USFDA, a Class II recall is initiated when use of or exposure to the offending product has resulted in temporary or medically reversible health effects or when the likelihood of serious adverse health effects is low.
Sun Pharma subsidiary
Sun Pharmaceutical Industries completed its merger with Taro Pharmaceutical Industries last year in a deal valued at $347.73 million. Following the merger, Taro is now a private company, wholly owned by Sun Pharma. Sun Pharma has been Taro’s majority shareholder since 2010.
Primarily focused on dermatology, Taro produces a wide range of prescription and over-the-counter products. Indian pharmaceutical companies supply a significant amount of medicines to US residents. In 2022, four out of ten of all prescriptions filled in the US were filled by Indian companies.