Hospira Inc., is recalling three lots of injectable opioid hydromorphone at the hospital/institution level because glass vials from these lots may be empty or cracked, in which case the sterility of the drug compromised. Use or exposure to hydromorphone from cracked glass vials may cause adverse events including cuts to health care professionals, and bloodstream infections, which may potentially lead to bacteremia or sepsis, to patients. Patients with compromised immune systems are at greater for infections.
The recall affects three lots of hydromorphone HCl injection, USP CII 10 mg/mL, 1 mL in 2 mL single dose vials with the lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots). Affected products were distributed nationwide to wholesalers, distributors, retailers and hospitals in the U.S. and Puerto Rico from October 2016 to July 2017.
Hydromorphone is an opioid agonist that is used to manage severe pain for which alternative treatments are not adequate. It is also used to treat opioid-tolerant patients who require higher doses of opioids for the management of severe pain.
Hospira has notified its customers of this recall and arranged for return of affected products. Anyone with these drugs on hand should stop using them immediately and quarantine them. Any adverse events should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice