Advanced Pharma d/b/a Avella of Houston has announced a voluntary recall of specific lots of Potassium Phosphate and Succinylcholine Chloride following a statement issued on June 16, 2017 by Hospira regarding microbial growth found during a routine simulation of its manufacturing process. The presence of microbial growth indicates a lack of sterility assurance, which may have affected recently manufactured products.
Select lots of Potassium Phosphate and Succinylcholine Chloride were produced using Hospira products, and were distributed to healthcare facilities across the U.S. The use of contaminated product may cause adverse events such as fever, chills and malaise; more serious adverse events include systemic bacterial sepsis and systemic invasive mycoses.
Potassium phosphate injection is indicated to prevent or correct hypophosphatemia as an additive to large volume intravenous fluids in patients with restricted or no oral intake. It is also used as an additive to specific intravenous fluid formulas when patients require more than standard electrolyte supplied in nutrient solutions.
Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgical procedures or mechanical ventilation.
Avella and Advanced Pharma are notifying their customers of the recall. Customers are advised to immediately discontinue the use of affected products, and to return any unused portion to Avella Specialty Pharmacy.
The full list of recalled Lot # and expiration dates can be found here.
For more information call (877) 292-4323 or visit FDA.gov.