FDA announces recalls due to lack of sterility assurance


The U.S. Food and Drug Administration (FDA) announced that Hospira, Inc., a Pfizer company, has voluntarily recalled selected lots of Sodium Bicarbonate Injection, Succinylcholine Chloride Injection, and Potassium Phosphates Injection 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 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. As a result of the Hospira recall, Advanced Pharma and PharMEDium Services are recalling specific lots of Potassium Phosphate and Succinylcholine, and Fagron Sterile Services is recalling three lots of Succinylcholine Chloride 20mg/mL 5mL syringe, which were repackaged and/or compounded using recalled Hospira products. Read the FDA safety alerts regarding the Hospira, Advanced Pharma, PharMEDium Services, and Fagron recalls.

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