FDA recall D-0596-2018

Product

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01

Reason for recall

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-02-07

Report date

2018-03-21

Termination date

2019-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0596-2018