Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Aidapak Services Llc Initiates Voluntary Recall of Selected Pharmaceuticals Repackaged by Aidapak Services Llc Due to Potential Incorrect Labeling
Aidapak Shipped Affected Products to Four States Only: Washington, Oregon, California, and Arizona
QA Coordinator – Robert Athy
Toll Free: 866.374.7665 Extension 3
FOR IMMEDIATE RELEASE August 16, 2013 – Vancouver, Washington. 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.
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. Products not stamped with AidaPak’s packaging stamp are not affected by this recall. Below is an example of AidaPak’s packaging stamp.
The potentially affected hospitals, Emergency Rooms, and clinics should:
- Stop distributing immediately; and
- Quarantine the products; and
- Email QA@aidapak.com for specific instructions regarding destruction or return of mislabeled products 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; and
- If you have further distributed this product to other hospitals or clinics, please notify them of this recall.
- If you dispense medication to patients being discharged on an outpatient basis, please contact those patients who may have received the impacted products.
Aidapak Services has notified its Customers by telephone, email and US Mail and is arranging for the destruction or return of all mislabeled product.
Aidapak Services will credit accounts for all recalled product destroyed or 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.
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.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.