FDA Recalls You Should Know About—Week of January 14, 2018

The FDA has announced that they will be working to expedite the release of recall information in an effort to “increase transparency, empower consumers, and enhance public health,” according to a recent press release.

Currently, the primary source for recall information is the FDA’s Enforcement Report which is released on a weekly basis online. If recalls have been classified into 1 of 3 categories based on how severe the hazard is, they are included in the report. Understanding the severity of the hazard help consumers take appropriate action, according to the FDA. However, recall classification can take a long time, ranging from weeks to months.

To remedy this, the FDA will begin to include “not-yet-classified” recalls in their weekly report so that the public can have the information sooner rather than later. In addition, the FDA has recently began positing early summaries pertaining to correction or removal actions of problematic medical devices in the Medical Device Recalls Database.

Here are the recalls you should know about for the week of January 14, 2018:

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter—January 16, 2018

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

Read the rest of the announcement, here.

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold—January 17, 2018

AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter.

Risk Statement: Use of a non-sterile injectable product could result in fatal infections in a broad array of patients. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.

Levofloxacin injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the specified conditions. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

Read the rest of the official announcement, here.

The following recall is no longer active:

Vermont Livestock Slaughter and Processing LLC, Recalls Ground Beef Due to Possible E. coli O157:H7 Contamination—Class I Recall, Health Risk High—October 13, 2017

Vermont Livestock Slaughter and Processing, LLC, a Ferrisburg, Vt., establishment, is recalling approximately 133 pounds of ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ground beef was produced on July 24 and 25, 2017.

• 1-lb. vacuum sealed packages containing “Bread & Butter Farm Ground Beef” with lot codes #072517BNB and #072417BNB.

The products subject to recall bear establishment number “EST. 9558” inside the USDA mark of inspection. These items were sold at Bread & Butter farm in Shelburne, Vt.

Read the rest of the original news release here.