Recall -- Firm Press Release

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Aidapak Services, LLC Initiates Nationwide Voluntary Recall on ALL Repackaged Pharmaceuticals by Aidapak Services, LLC Due to Potential Cross Contamination with Beta Lactam Products

Contact:
Consumer:
866-374-7665

Media:
Jim Barratt
866-374-7665 x3
qa@aidapak.com

FOR IMMEDIATE RELEASE - June 1, 2011 - Vancouver, Washington, Aidapak Services, LLC is conducting a nationwide voluntary recall to Hospital Inpatient Pharmacies for the products listed on the company’s website. The firm voluntarily recalled these products after learning of the potential cross contamination of non-penicillin drug products repackaged in the same facility. There is potential likelihood that a serious anaphylactic reaction in patients, with known hypersensitivity to beta-lactam or penicillin products, could result from receiving these products. This poses potential serious risk to a patient’s health.

Please click on the link provided below to view a complete listing of products affected by this recall. All products affected by this recall are stamped with Aidapak's packaging stamp.

http://aidapak.com/Recall/FDA%20Recall%20List%2020110601.pdf

There have been no reports of injuries reported to date.

Hospitals, Emergency Rooms, clinics and other healthcare facilities:

• Stop distributing immediately; and
• Quarantine the products; and
• Email QA@aidapak.com for a Returned Material Authorization (RMA) for a returns packet and instructions for returning the product within 30 days; or
• Call Aidapak’s Recall Coordinator at 360-448-2090 (extension 3) or 866-374-7665 (extension 3) for a Returned Material Authorization (RMA) for a returns packet and instructions for returning the product within 30 days.

Aidapak Services is notifying its Customers by email and US Mail and is arranging for the return of all recalled product.

Aidapak Services will credit accounts for all recalled product returned to Aidapak Services. Those with questions about the return or recall process, please call our Quality Assurance Group at 360.448.2090 (extension 3) or 866-374-7665 (extension 3), Monday through Friday 8:00AM PDT to 5:00PM PDT.

Aidapak Services has instituted a complete cleaning and decontamination of our facilities followed by testing by two separate laboratories to ensure the absence of any penicillin or non-penicillin beta-lactam contaminates.

Any adverse reactions experienced with the use of these products should be reported to Aidapak Services, LLC Quality Assurance Group at 360.448.2090 (extension 3) or 866.374.7665 (extension 3), qa@aidapak.com.

Adverse reactions or quality problems experienced with the use of any of these products may be reported to the FDA's MedWatch Adverse Event Reporting program online or regular mail or by fax:

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
  www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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