Recall: Genentech Activase (alteplase) 100mg Vials
On 2017-09-06, the FDA announced that Genentech is conducting a recall on Activase (alteplase) 100mg Vials due to a possible lack of sterility. The recalled products were sold under the brand name(s) Genentech during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 10 drugs recalls due to potential lack of sterility, including hydromorphone hcl, levophed, all lots of unexpired sterile drug products and more. Additionally, there have been 18 drug and medical device recalls due to other health hazards as well as 105 food recalls.
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Activase (alteplase) 100mg vials
Brand Name(s): Genentech
Reason for Recall: Lack of Sterility Assurance of the Sterile Water for Injection
Official Recall Date: 2017-09-06
Additional information provided by the FDA.gov:
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.