Sun Pharmaceutical Industries, Inc. is voluntarily recalling one batch of its DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL within the U.S. to the hospital/user level, following the detection of glass particles during production. The recall affects 675 vials from Lot # HAG2581B, with an expiration date of May 31, 2027.
The presence of glass particles in intravenously administered medication poses potential patient safety risks, including local irritation, swelling, blockage of blood vessels, and life-threatening blood clot events. Sun Pharma has confirmed that, to date, no adverse events related to this specific batch have been reported. The company has investigated the issue and implemented corrective and preventative actions.
DOXOrubicin Hydrochloride Liposome Injection is prescribed for the treatment of Ovarian cancer, AIDS Related Kaposi Sarcoma, and Multiple Myeloma. The affected product can be identified by the Aisling label, specifically NDC 72603-200-01.
Sun Pharma is actively notifying its distributors and customers to arrange for the return or replacement of all recalled products. Hospitals and users possessing the affected batch are advised to cease use immediately and return or discard the product. Patients who have experienced any problems potentially linked to this drug should contact their physician or healthcare provider.