FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

Discoloration Sparks PharMEDium Recall of Norepinephrine Bitartrate

Jan. 11, 2016

PharMEDium Services is recalling certain lots of norepinephrine bitartrate following hospital complaints of discoloration.

The recall affects 29 lots of the 4-mg version and three lots of the 8-mg version. The product — which is added to 0.9 percent sodium chloride in a 250-mL Viaflex bag — is used for blood pressure control in certain acute hypotensive states. Discoloration in the admixture indicates degradation and could result in decreased potency. No adverse events have been reported.

The company notified customers on Dec. 22, 2015, and requested quarantine and destruction.