Hair Contamination Leads to Hospira Aminosyn Recall

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By: Russell Maas | Published: September 4th, 2013

A recall has been issued for one lot of amino acid injection fluid manufactured by Hospira, after a consumer complaint was received involving at least one vial that was contaminated with hair.  

The Aminosyn II recall was announced by the FDA on August 30, after a consumer found foreign matter in the solution, which Hospira later confirmed to be a human hair follicle.

The affected lot of Aminosyn is an amino acid injection used at the user level to inject nitrogen and other vitamins for nutritional support for patients who are not capable of receiving oral nutrition is pill form.

Although no injuries have been reported in connection with the use of the amino acid injection fluid, injection of contaminated medications may cause a wide variety of problems depending upon a patient’s condition. According to the recall notice, patients typically may experience inflammation, phlebitis, and or low levels of allergic response but patients with more severe conditions with preexisting trauma may experience occluded capillaries and other high level risks.

The recall includes Aminosyn II 10%, Sulfite-Free, 500mL flexible containers with NDC number 0409-4164-03, Lot number 26-138-JT and has an expiration date of August 1, 2014. The affected lot was manufactured by Hospira Inc. and distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between March 2013 and August 2013.

Hospira has been associated with multiple recalls over the past few years due to particulate matter contamination. Earlier this year, Hospira Inc. recalled one lot of .09% sodium chloride injection following a consumer complaint indicating particulates within the fluid which after further investigation were identified in four tested samples.

Additionally, Hospira recalled 15 lots of Pipercillin and Tazobactam injection fluids as well as their GemStar Infusion System simultaneously due to particulate matter contamination and voltage defects in the infusion system.

Those with existing product should verify the solution is part of the recalled lot and stop using/distributing the product immediately and quarantine it until they have called Stericycle at 1-866-737-4701 to arrange a return and replacement of the injection fluid.

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