June 26, 2017

FDA: Fagron Sterile Services recalls three lots of succinylcholine

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on June 23 posted the recall by Fagron Sterile Services (Wichita, Kansas) of three lots of succinylcholine chloride 20 mg/mL 5 mL syringes because of microbial growth detected during a simulation of the manufacturing process. This is a secondary recall of products manufactured by Hospira and repacked by Fagron.

Succinylcholine chloride injection is used as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Posted 06/23/2017] AUDIENCE: Pharmacy, Critical Care Medicine ISSUE: Fagron Sterile Services is voluntarily recalling three (3) lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services, is due to microbial growth detected during a routine simulation of Hospira's manufacturing process, which represents the potential introduction of microorganisms into the product.

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