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Friday, May 24, 2019

RECALLS

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Drugs Due to a Potential Lack of Sterility Assurance
FOR IMMEDIATE RELEASE – Houston, Texas, Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.

The recall encompasses all compounded sterile drug products, within expiry, that were dispensed within from October 24, 2018 to May 21,2019. The sterile drug products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The recall does not affect the pharmacy's non-sterile compounded products or retail pharmacy operations.

The Village Company Issues Voluntary Nationwide Recall of La Bella Extreme Sport Styling Gel Due to Bacterial Contamination
On May 24, 2019, The Village Company initiated a voluntary nationwide recall of the 22-ounce La Bella Extreme Sport Styling Gel. Four lots failed micro testing due to bacterial contamination, resulting in potential contamination of 2,377 cases (or 9,508 units). The bacteria found is Burkholderia cepacia and a group of related strains.

Burkholderia cepacia and group of related strains rarely cause infections in healthy people, but pose serious risk to individuals with cystic fibrosis, weakened immune systems, and chronic lung disease. If you are feeling ill after having used the product, consult with your doctor. Washing your hands, hair brush, combs and other hair items, counter tops and other surfaces with warm soapy water are good practices to help prevent the spread of bacteria.

The Village Company has not received any reports from consumers related to this recall. Consumers who have a product from any of the affected lots should stop using it immediately.

The recalled La Bella Extreme Sport Styling Gel was manufactured by Kapra Cosmetics, Inc. (Kapra) and distributed to retail starting March 5, 2019.

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