Recall of Hydromorphone HCL Injection USP by Hospira

PUBLISHED: Mar 6, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospice, Hospitals, Long Term Care

Hospira is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital/institution level. Hospira initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.

Cracked vials may compromise the sterility of the product. Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals. Intravenous infusion of a non-sterile solution can lead to bloodstream infections, which may potentially lead to bacteremia or sepsis. These infections are of concern especially to immunocompromised patients.

Product was distributed nationwide to wholesalers/distributors/retailers/hospitals in the United States and Puerto Rico from October 2016 to July 2017.

Hospira, Inc. has notified wholesalers/distributors/retailers/hospitals by recall letter to arrange for return of any recalled product. Wholesalers/distributors/retailers/hospitals with an existing inventory of the lots subject to this recall should stop use and distribution of the remaining units and quarantine immediately. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Read the MedWatch Safety Alert, including a link to the FDA Recall notice, at the link below.

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