FDA recall D-1082-2017

Product

Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.

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-1082-2017