Avella Specialty Pharmacy Recalls Sterile Products Due to Potential Inaccuracy of Latex Free Label

These products were not distributed directly to patients or consumers, but rather to healthcare facilities

Avella Specialty Pharmacy Recalls Sterile Products Due to Potential Inaccuracy of Latex Free Label
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February 28, 2017

Advanced Pharma Avella of Houston is conducting a recall of all unexpired sterile injectable products labeled latex free that were produced at Advanced Pharma Houston location between September 1, 2016 and February 16, 2017. The affected products were sold to the user level (hospitals and institutions) because such products may contain synthetic latex and/or natural latex.

Avella and Advanced Pharma have been unable to confirm with clarity whether its latex free label statements are accurate in all cases and are therefore conducting this recall in an abundance of caution. The risk of potential adverse events related to a latex allergy, while rare, can range from local site reactions including swelling and inflammation to allergic reactions which could be life-threatening to users who are sensitive to latex. These products were not distributed directly to patients or consumers, but rather to healthcare facilities (hospitals and institutions).

Avella Specialty Pharmacy is committed to patient safety in all instances and is therefore issuing this recall in an abundance of caution, although certain of the products subject to this voluntary recall may in fact be devoid of synthetic and/or natural latex. The issue is segregated to the Houston location and no other Avella Specialty Pharmacy locations. To date, no reported adverse events or patient safety issues have been reported as a result of the "latex free" labeling.

Avella Specialty Pharmacy is notifying customers of the voluntary recall by phone and mail. Customers in Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Mississippi, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, or Virginia that have any of the affected medications labeled with latex free that are being recalled should immediately discontinue use and return the unused portion to Avella Specialty Pharmacy. For a full list of Advanced Pharma products, visit AdvancedPharma.com.

Patients and healthcare providers with any additional questions or concerns regarding this recall can contact the Advanced Pharma recall line at (877) 292-4323.