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FDA Safety Alerts

January 4, 2018

These Food and Drug Administration (FDA) Safety Alerts were recently issued:

 

Class I Recall: Reprocessed Agilis Steerable Introducer Sheath

Certain lots of the Sterilmed reprocessed Agilis Steerable Introducer Sheath have been recalled due to improper seal of the sheath hub. This product is used during cardiac catheterization procedures. Improper seals can allow blood to leak through the hub, cause the cap to fall off during a procedure, or can create a difference in pressure that allows air into the circulatory system. More Information.

 

Recall of Auromedics Ampicillin and Sulbactam for Injection

Auromedics Pharma LLC is voluntarily recalling lot AFO l 17001-A of ampicillin and sulbactam for injection, 1.5 g in a single-dose vial because the product has been found to contain glass particles. More Information.

 

Certain Compounded Drug Products Recalled by PharMEDium Services

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling certain lots of drug products to the hospital/user level due to a lack of assurance of sterility. The company has not received any reports of complaints related to these products to date. More Information.

 

Auromedics Pharma Recalls Linezolid Injection 600mg/300mL Flexible Bags

Auromedics Pharma is voluntarily recalling 1 lot of Linezolid Injection 600mg/300mL flexible bags, due to the presence of white particle matter which has been identified as mold. More Information.