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FDAnews Drug Daily Bulletin

PharMEDium Pulls Sterile Preparations Over Particulate Matter

May 16, 2016

Lake Forest, Ill.-based PharMEDium Services is recalling all lots of sterile preparations mixed with Fresenius Kabi’s local anesthetic Sensorcaine-MPF after an inspection uncovered glass-like particulate matter in the anesthetic.

The nationwide recall, which is being overseen by Inmar Pharmaceutical Services, is taking place at the hospital level.

Fresenius Kabi warns that contaminated solutions may cause local inflammation, disrupt tissue or trigger an immune response. Additionally, the particulate matter could potentially delay treatment.

 

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