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FDA MedWatch - LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage

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FDA MedWatch CareFusion EnVe and ReVel Ventilators

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FDA MedWatch ICU Medical ConMed Stat2 Flow Controller

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Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling

Tuesday, August 20, 2013

AUDIENCE: Pharmacy, Health Professionals, Patients

ISSUE: Aidapak Services LLC, is conducting a voluntary recall of specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in the States of Washington, Oregon, California, and Arizona for products listed on the company’s website. The Firm voluntarily recalled these products to the hospital/user level after learning of possible incorrect labeling which could involve OTC, prescription, and dietary supplement products.

Some of the products, if incorrectly labeled, could result in patients receiving drugs that were not prescribed, which could result in allergic reactions or other undesired effects.  Pregnant women could receive a drug that they should not take or, as a result of receiving an incorrect medication, patients may not receive proper treatment of their disease or condition. This may pose serious or life-threatening risk to a patient’s health.

BACKGROUND: AidaPak shipped affected products to four states only: Washington, Oregon, California, and Arizona. Products affected by this recall are limited to strip packs packaged between May 1, 2013 and July 1, 2013, single-use dosage form, intended specifically to be administered to hospital patients while admitted to the hospital. All products affected by this recall are stamped with AidaPak’s packaging stamp (see Photo link below).

RECOMMENDATION: The potentially affected hospitals, Emergency Rooms, and clinics should stop distributing immediately and quarantine the products. Hospitals that may have sent product to other hospital pharmacies or clinics should contact them and make them aware of the recall. If you dispense medication to patients being discharged on an outpatient basis, please contact those patients who may have received the impacted products. Patients who were given prescriptions by a hospital’s outpatient pharmacy to be taken home should check the name and pedigree number against the recalled list provided in the Firm Press Release (http://www.aidapak.com/Recall/RecallItemList-20130816.pdf1).
The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm2

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