Advanced Pharma Inc., doing business as Avella of Houston, issued a recall of all unexpired sterile injectable products labeled “latex free” produced at Advanced Pharma’s Houston location from Sept. 1, 2016, to Feb. 16, 2017, because they may contain synthetic latex and/or natural latex.
Avella and Advanced Pharam have been unable to confirm whether the “latex free” label statements on their products were accurate in all cases, and issued the recall as a precaution. The risk of potential adverse events related to a latex allergy range from local site reactions including swelling and inflammation to allergic reactions, which can be life threatening to users who are sensitive to latex.
The products were not distributed directly to patients or consumers, but rather to health care facilities such as hospitals and institutions, in the following states: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Mississippi, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia. The companies are contacting health care facilities with affected products and informing them of the recall and instructing them to immediately discontinue use and return the unused portion to Avella Specialty Pharmacy. A full list of Advanced Pharma products can be found here.
Any side effects related to recalled sterile products produced by Advanced Pharma should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.