Genentech Recalls Three Lots of Activase Due to Lack of Sterility Assurance of the Sterile Water for Injection – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
Genentech, a member of the Roche Group, is voluntarily recalling three lots of Activase® (alteplase) 100 mg vials that were co-packaged with sterile water for injection and distributed to hospitals nationwide. The vials of sterile water for injection, manufactured by Hospira, Inc, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking. Each 100 mg Activase vial (58 million IU) is packaged with diluent for reconstitution (100 mL sterile water for injection, USP), and one transfer device. The National Drug Code is 50242-085-27 for the affected lots, which are listed in a press release. To date, Genentech has not received reports of adverse events associated with use of impacted sterile water for injection. Health care providers who have the recalled lots of Activase should stop using the product and return it to Genentech. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting Program.