PharMEDium Services has issued a voluntary recall of a total of 32 lots of norepinephrine bitartrate used to help treat blood pressure following complaints of discoloration in the admixture.
The company's press release was posted on the FDA's website and said 29 lots of 4-milligram norepinephrine bitartrate added to 0.9% sodium chloride in 250-milliliter Viaflex bags and three lots of 8 milligram norepinephrine bitartrate added to 0.9% sodium chloride in 250-milliliter Viaflex bags were the target of the recall.
The company said it received complaints from hospitals that there was discoloration in the product, which can be an indication of degradation and could result in decreased potency due to oxidation. A decrease in the potency could lead to a delay in the patient getting the desired effect of the drug.
The product is typically used to control blood pressure for people suffering certain types of hypotensive states. There have been no reports of adverse cases related to the recall, the company said.
|Tim Guttman, AmerisourceBergen CFO|
In November, AmerisourceBergen ($ABC) closed a $2.6 billion deal to buy PharMEDium that followed FDA findings in July that the compounder's Cleveland, OH, facility hadn't resolved issues over insufficient environmental monitoring of the aseptic processing area and the company's failure to do lab analysis to identify the strength of the active ingredient in drugs before they were sent to hospitals.
Inspectors also found that the lab was still not doing endotoxin testing or sterility testing on all products, even though some of those are "sterile injectable drug products including epidural and intrathecal injections and components labeled for IV use only."
During a Q2 conference call, CFO Tim Guttman said AmerisourceBergen was committed to investing and resolving the issues.
- check out the release on the FDA website