FDA recall D-1081-2017

Product

Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50

Reason for recall

Presence of Particulate Matter: Silicone oil

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-07-26

Report date

2017-08-16

Termination date

2018-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

LAKE FOREST, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1081-2017