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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
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.
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. Hospitals that may have sent product to other hospital pharmacies or clinics should contact them and make them aware of the recall. 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 link below to see if they have affected product. There have been no reports of adverse reaction or injuries to date. All 25 hospitals potentially affected by this recall have been notified and have been in direct contact with AidaPak Services LLC regarding this recall. All but 1 of the 25 hospitals has responded that the potentially affected drugs currently in inventory are properly labeled.
To view the original firm press release and a weblink to a complete listing of products affected by this recall, please visit: Aidapak.
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