Pfizer’s Hospira Voluntarily Recalls 42 Lots of Sodium Bicarbonate for Sterility Assurance Issues

Hospira, a Pfizer company, is voluntarily recalling multiple lots of sodium bicarbonate for injection and other products due to sterility-assurance issues.

The company is recalling 42 lots of 8.4% sodium bicarbonate -injection, USP, 50-mL vials, five lots of Neut (sodium bicarbonate 4% additive solution) 5-mL vials, five lots of Quelicin (succinylcholine chloride Injection, USP) 200-mg/10 mL vials, and seven lots of potassium phosphates Injection, USP, 45-mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

In a notice by the US Food and Drug Adminstration, the agency said that 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; however, the agency added that the possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated.

The lots were distributed nationwide in the US (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. Pfizer is working to restore supply of these products and is in communication with the FDA to address any supply issues.

Sodium bicarbonate Injection, USP, is indicated in the treatment of metabolic acidosis, in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol, and in certain hemolytic reactions. Sodium bicarbonate is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate. Neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion.

Quelicin (succinylcholine chloride Injection, USP) is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Potassium phosphates Injection, USP 3 mM P/mL (millimoles/mL) is indicated as a source of phosphorus, for addition to large-volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

Source: FDA

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