Drug Safety Alerts

Hydromorphone HCl Injection Class I Recall

3/21/18

On March 21, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding Class I recalls of hydromorphone hydrochloride injection C-II 10 mg/mL 1 mL single-dose vials manufactured by Hospira (a Pfizer company) and distributed by Hospira and Teva Pharmaceuticals. This recall was issued due to the potential that units from the affected 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.

A complete list of the affected products and lot numbers is providedhere:

CVS Caremark Response:

These products are not carried by theCVS Caremark Mail Service Pharmacies

For more information about this recall, please contact Pfizer Safety at 1-800-438-1985. You may also call the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332).

To view the FDA recall notice regarding this recall, please click on the link below:

https://www.fda.gov/Safety/Recalls/ucm599442.htm.