FDA Drug Class II — Moderate

HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)

Hazard

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Products

HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
Brand
Pfizer Inc.
UPC
Lot: 760853A

Units Affected

115,370 vials