HelloLife Voluntary Recall of Neuroveen, Respitrol, Thyroveev and Compulsin

PUBLISHED: Aug 31, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office, Pharmacy, Rural Health Clinics

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia.

Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table below) that were manufactured at the King Bio, Inc facility in Asheville, NC.

Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals. To date, HelloLife, Inc. has not received any reports of adverse events related to the recalled products.

Please see the recall notice, link below, for specific lot number and package details.

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

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