FDA Recall Alert: Hospira Announces Nationwide Voluntary Recall of Seven Lots of Propofol Injectable Emulsion, USP, Due to Visible Particulates

This morning, the Food and Drug Administration (FDA) alerted providers that Hospira, Inc. is conducting a nationwide recall of seven lots of Propofol Injectable Emulsion, USP, to the user level due to a glass defect located on the interior neck of the vial, which was identified during a retain sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis. To date, Hospira has not received reports of any adverse events associated with this issue for these lots.

The affected lots were distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through December 2013.

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), NDC Number: 0409-4699-30.

The lot numbers affected by the recall are:

  • 29-614-DJ
  • 29-615 DJ
  • 29-616 DJ
  • 29-617 DJ
  • 29-628 DJ
  • 29-629 DJ
  • 29-630 DJ

All lots have the expiration date May 1, 2015.

On April 2, 2014, Hospira notified its customers via recall letter that the company had implemented corrective actions to the manufacturing process to prevent recurrence.

Customers have been advised to check inventory and immediately quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Affected product should be returned to Stericycle, which can be contacted at 1-877-272-2158 (M-F, 8 a.m. - 5 p.m. ET).

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by mail or by fax.

If you need additional information, please contact Ashley McGlone, manager of regulatory affairs, at amcglone@ascrs.org or 703-591-2220.

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