cist complained about "great concerns over the safety" of Ameridose
NaCl. The "drug is filled into an empty Hospira bag. This bag can be
directly attached to any IV line and infused undiluted into a patient.
The warning says 'May need to dilute'. There is no circumstance
where this product would not need to be diluted prior to infusion. ...
As a practicing pharmacist, I'm shocked that such a product would be
allowed to be distributed."
In a February 2011 e-mail, an FDA official agreed. The NaCl is
"extremely dangerous. ... How is Ameridose even obtaining these
empty Hospira 100mg bags? The way that these bags appear and are
labeled is very misleading ... and to say that 'CAUTIONCONCENTRATION:
MAY NEED DILUTE' is an understatement. ... This is unbelievable!"
Early in 2012, FDA received more reports.
• Confusing labeling on Ameridose fentanyl resulted in 2 near miss-
es where nurses had "almost given their patients 100mcg instead of
50mcg."
• A doctor put a patient on a heparin drip, then sent out for labs.
The patient's level didn't change. Upping the drip did nothing.
Changing the bag didn't help. When the pharmacy tested the 2 bags,
neither contained any heparin.
• Health professionals complained about the potency of pain med-
ications made by Ameridose. FDA asked the company to investigate.
It never did.
The FDA did nothing more with the info. "FDA officials reacted as
though Ameri dose was a nuisance it could not figure out how to
resolve, rather than a ticking time bomb," charges a report from the
House Committee on Energy and Commerce.
Director of Compliance Mutahar Shamsi was furious with FDA's
legal department. "[We] spent a lot of time developing this case. ...
Having it 'closed' for nebulous reasons is troubling ... [and] frustrating.
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