Because of microbial growth detected during a routine simulation of the manufacturing process (which represents the potential introduction of microorganisms into the products), Hospira is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials; 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials; 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials; and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level.
In the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue.
These lots were distributed nationwide in the U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore to wholesalers and hospitals from January to June 2017. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Read the FDA release
