Potential Microbial Growth Prompts Recall of Several Injectable Solutions

The recall was instigated after a microbial growth was discovered in the manufacturing process
The recall was instigated after a microbial growth was discovered in the manufacturing process

Hospira announced a recall of 59 lots of several injectable solutions as a precautionary measure due to microbial growth discovered during a routine simulation of the manufacturing process:

  • 42 lots of Sodium Bicarbonate Injection, 50mL vials
  • 5 lots of Neut (sodium bicarbonate 4% additive solution), 5mL vials
  • 5 lots of Quelicin (succinylcholine chloride injection), 200mg/10mL vials
  • 7 lots of Potassium Phosphates Injection, 45mM vials

The detection of microbial growth indicates the possible introduction of microorganisms into the products. If a contaminated product is given to a patient, adverse events such as fever, chills, and malaise are likely to occur. Severe adverse events include systemic invasive mycoses or systemic bacterial sepsis. 

Sodium Bicarbonate Injection is used to treat metabolic acidosis, certain drug intoxications, salicylate or methyl alcohol poisoning, and certain hemolytic reactions. It is also indicated for use in severe diarrhea. Neut is used as an additive to increase the pH of acid solutions given intravenously to reduce chemical phlebitis and discomfort due to vein irritation. 

Quelicin is used as an adjunct to general anesthesia to aid tracheal intubation, and for muscle relaxation during surgery or mechanical ventilation. 

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Potassium Phosphates Injection is added to large volume intravenous fluids to prevent or correct hypophosphatemia in patients with limited or no oral intake. It is also used to help prepare specific intravenous fluid formulas when the patient requires more than standard electrolyte/nutrient solutions. 

The affected lots were distributed in the U.S, Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore between January to June 2017. Hospira reported that no batches of the product have been identified as containing microorganisms. No adverse events associated with this recall have been reported. 

Hospira is notifying its customers via a recall letter and is arranging for product return and Pfizer is working to restore supply of these products. The full list of recalled Lot # are found

For more information visit FDA.gov.