Recall: D-686-2013

Class II - Potentially Harmful

Class IIClassification

2013-05-02Initiated

TerminatedStatus

Hospira Inc.Firm

Product

Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.

Reason

Presence of Particulate Matter: visible particles were identified floating in the primary container.

Distribution

Nationwide

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