Hospira, Inc., a Pfizer company, 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, Inc. 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. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.
Hydromorphone HCl is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is also indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials, is packaged in a carton of 10 x 1 mL Single- dose vials. The affected lots include the following NDC, lot numbers and expiry dates. Product was distributed nationwide to wholesalers/distributors/retailers/hospitals in the United States and Puerto Rico from October 2016 to July 2017.