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

Recall date

August 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1167-2017

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

United States Nationwide (including Puerto Rico) and Singapore

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)