• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

  • Print
  • Share
  • E-mail

Product Detail

Product Description Gentamicin Sulfate Injection USP 80 mg/2mL(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.
Recall Number D-686-2013
Classification Class II
Code Info Lot 07-067-DK Exp. 07/13
Product Distributed Qty 168,300 vals
Reason For Recall Presence of Particulate Matter: Confirmed customer report where visible particles were identified floating in the primary container.

Event Detail

Event Id 65226
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide