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FDA Recalls That Should Be on Your Radar

MAY 12, 2018 | KRISTI ROSA
We’ve rounded up a list of important US Food and Drug Administration (FDA) recalls that you should know about from this past week. Check them out:

Badger Botanicals Recalls Several Kratom Products Due to Potential Salmonella

Badger Botanicals, LLC, recalls Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements due to potential Salmonella contamination.

The recalled products were sold in pouches of 250g directly to consumers through the company website from January 1, 2018 to April 12, 2018. The noted the potential contamination after the FDA sampled and tested the product and found that Salmonella was present.

There is currently an ongoing multistate outbreak of Salmonella infections linked with kratom products. For the most recent case counts and states affected by the outbreak, be sure to check out our Contagion® Outbreak Monitor.

For more information, be sure to check out the official press release.
 

Anesthesia Machines Recalled Due to Production Step Error

Dräger Medical has issued a recall for the Fabius Anesthesia machines because excessive oil that had not been removed at the time of production. According to the FDA, excess oil could potentially impede the position detector of the ventilation motor during operation, thus causing ventilation to fail. If ventilation fails, this could result in severe, potentially life-threatening health consequences.

The Fabius Anesthesia machines are used in operating, induction, and recovery rooms at hospitals as well as at Magnetic Resonance Imaging (MRI) settings for patients of all ages.

For more information, read the official recall announcement.
 

Ampicillin and Sulbactam for Injection USP Recalled Due to Presence of Red Particulate Matter

AuroMedics Pharma has issued a voluntary recall for 2 lots of ampicillin and sulbactam for injection USP—3 g/single-dose vials—down to the hospital/user level. The recall came as a result of customers complaining of red particulate matter seen in the product, which is believed to be red rubber particles from the manufacturing process of the active ingredients, according to the FDA.

If the particulate is administered into a patient, it could result in any of the following complications: local site reaction, phlebitis, pulmonary granuloma, occlusion of blood vessels, thromboembolic events and systemic immune responses. Furthermore, those with vascular disease run the risk of experiencing embolic events which could ultimately result in permanent impairment or damage to a body structure or function.

For more information about the recall, read the official safety alert.
 

Piperacillin and Tazobactam for Injection, USP Recalled Due to Particulate Matter

AuroMedics Pharma issued another voluntary recall for 2 lots of piperacillin and tazobactam for injection, USP 3.375 g, in a single-dose vial to the hospital level. The products were found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.

If a glass particulate is administrated via an intravenous drug, it could result in local irritation or swelling in response to foreign material. However, this could also result in more serious, even deadly outcomes, such as blockage and clotting in blood vessels.

For more information, read the official safety alert.


Medline Remedy Essentials Recalls No-Rinse Cleansing Foam Due to Burkholderia cepacia

Shadow Holdings dba Bocchi Laboratories has recalled certain lots of Medline Remedy Essentials No-Rinse Cleaning Foam due to potential B. cepacia contamination. The skin product is used in hospitals and home health care settings for individuals who cannot shower or bathe after surgery or because of other acute health conditions.

The FDA has announced that they are currently investigating a multistate outbreak of B. cepacia complex that have been linked to these products. For the most recent case counts and states affected, be sure to check out the Contagion® Outbreak Monitor.

For more information, be sure to check out our recent coverage.
 

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit Recalled Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medial has issued a recall for the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in product design that could potentially result in difficulty or the inability to disconnect the mask from the elbow of the resuscitator.

For more information, be sure to check out the official safety alert.
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