June 19, 2017

FDA: Hospira recalls Sodium Bicarbonate, Quelicin, and Potassium Phosphates injections

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on June 16 announced the recall by Hospira, Inc, a Pfizer company, of the following:

  • 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials
  • 5 lots of Neut (Sodium Bicarbonate 4% additive solution) 5 mL vials
  • 5 lots of Quelicin (Succinylocholine Chloride Injection, USP) 200 mg/10 mL vials
  • 7 lots of Potassium Phosphates Injection, USP, 45 mM vials.

The recall was initiated because of microbial growth detected during a routine simulation of the manufacturing process. Patients receiving these products may experience adverse events ranging from fever, chills, and malaise to systemic invasive mycoses or systemic bacterial sepsis.

The products were distributed from January to June 2017.

Posted 06/16/2017] AUDIENCE: Pharmacy, Critical Care Medicine, Nursing Please view the ISSUE: Hospira, Inc., a Pfizer company, 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 due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

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