Pfizer Inc. recalls HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc.,

Recalled September 27, 2017 · FDA recall D-1167-2017 · Pfizer

Hazard

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

Units

115,370 vials

Sold at

United States Nationwide (including Puerto Rico) and Singapore

Description

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

Product

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)

Manufacturer(s)

Pfizer Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →