News & Press: Patient Safety

Recall Alert: Hydromorphone HCl by Hospira

Monday, September 11, 2017  
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SIS Patient Safety Alert 09/08/2017: Hydromorphone HCl by Hospira: Recall - Lack of Sterility Assurance

This is an important alert from the Spine Intervention Society. We send out Patient Safety Alerts when we receive important information regarding products or services that can impact your patients' safety. When companies announce a recall, market withdrawal, or safety alert, the U.S. Food and Drug Administration (FDA) posts the company's announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCl Injection, USP, CII (2 mg/mL) 1mg/mL Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.

The recalled lots were distributed nationwide in the US (including Puerto Rico), Singapore, and Taiwan to wholesalers and hospitals from May 2017 to July 2017.

Click here for detailed information about this recall

Source: U.S. Food and Drug Administration (FDA) (Accessed: 09/08/2017)

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