Hospira Recalls Sodium Bicarbonate
The company recalled a variety of products due to the potential of microbial contamination.
On June 15, 2017, Hospira, a Pfizer company, announced it was 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. The recall is due to the detection of microbial growth during a routine simulation of the manufacturing process. The recalled lots were distributed nationwide in the United States (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore to wholesalers and hospitals from January to June 2017.
The microbial growth found in the simulated processes indicates the possibility for the introduction of microorganisms into product. Hospira is investigating the root cause so it can determine corrective actions and preventive actions. Pfizer announced it is working to restore the supply of these drugs.
According to Hospira, use of contaminated products could result in adverse events including fever, chills, malaise, systemic invasive mycoses, or systemic bacterial sepsis. The company states the possibility of a “breach of sterility assurance” on products already distributed is remote but cannot be eliminated. The company has not identified any contaminated distributed product as of June 15 nor has it received any complaints of adverse events.
Source: FDA
