Recall: D-0597-2018

Class I - Dangerous

Class IClassification

2018-02-07Initiated

TerminatedStatus

Pfizer Inc.Firm

Product

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

Reason

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.