US FDA Orders Sun Pharma's Taro to Recall 17,664 Units of Antifungal Shampoo Amid Safety Concerns
Image Source: Internet
The US Food and Drug Administration (USFDA) has issued a Class II recall notice to Sun Pharma's Taro Pharmaceutical Industries, a leading Indian pharmaceutical company, to remove over 17,000 units of Ciclopirox Shampoo from the US market. The recall is due to manufacturing issues, as the shampoo failed to meet impurity and degradation specifications. Ciclopirox Shampoo is used to treat seborrheic dermatitis, a condition characterized by dry, flaky, and itchy skin. The affected units, totaling 17,664, were distributed nationwide in the US and were initiated for recall on December 9. Sun Pharma acquired Taro in 2010 and completed the merger in a deal worth $347.73 million last year. As a result, Taro is now a private company and wholly owned by Sun Pharma. This recall is a significant development in the US pharmaceutical market, where Indian companies supply a substantial proportion of drugs to residents. In 2022, four out of ten prescriptions filled in the US were supplied by Indian companies, highlighting the country's growing presence in the global pharmaceutical industry. The USFDA has categorized this recall as Class II, indicating that the use of the violative product may lead to temporary or medically reversible health consequences.
