FDA recall D-1167-2017

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)

Reason for recall

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

Distribution

United States Nationwide (including Puerto Rico) and Singapore

Key facts

Status

Terminated

Initiation date

2017-08-22

Report date

2017-09-27

Termination date

2023-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1167-2017