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.
American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall
Units for Pharmacy Automated Equipment Part of Broader Recall
Michael N. Kilpatric
FOR IMMEDIATE RELEASE -- Valley Forge, PA -- March 20, 2008 --- American Health Packaging (AHP), a subsidiary of AmerisourceBergen Corporation (NYSE:ABC), today announced a voluntary recall of 1,421 units (25 vials per unit) of 10000 USP units/ml heparin sodium injection 1ml vials as part of the broader February 29, 2008 recall of Heparin products made by Baxter Healthcare Corporation. The vials were manufactured by Baxter and then placed by AHP into individually labeled bags for use in pharmacy automation equipment. The AHP packages where sold to five hospitals in Georgia and California, all of whom were notified of the recall earlier this month. Baxter Healthcare will reimburse AHP for the recalled product.
The recalled products are APS HEPARIN 10MU/ML (10000 USP units/ml) 1ml SDV 25UD (bag) NDC # 00641-0410-25, lot numbers 074155, 073089, 073391, 073613, 070095A, 073712, 072907, 073454, 070095D and APS HEPARIN SDV 10MU (10000 USP units/ml) 1ml 25UD (box and rod) NDC # 00641-0410-25, lot numbers 070095B, 070095C, 068286, 067755. AHP instructed customers to return any and all of these product lots remaining in inventory.
This recall was initiated due to the Baxter Healthcare's recall which stated, ".voluntary recall of Heparin Sodium Injection to include all lots of single and multi-dose vial products, due to an increase in reports of adverse patient reactions including abdominal pain, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnia, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, including profound and refractory hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal adema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. The reports of profound and refractory hypotension usually occur with the first few minutes of bolus administration."
This recall is being made with the knowledge of the Food and Drug Administration. Heath care professionals with questions about the AHP packages should contact Richard J. Augustine at 1-800-707-4621. To report adverse drug events or for information on the Baxter Healthcare recall of all Heparin Sodium Injection products, please contact Baxter Healthcare at 1-800-667-0959.
AmerisourceBergen is one of the world's largest pharmaceutical services companies serving the United States, Canada and selected global markets. Servicing both pharmaceutical manufacturers and healthcare providers in the pharmaceutical supply channel, the Company provides drug distribution and related services designed to reduce costs and improve patient outcomes. AmerisourceBergen's service solutions range from pharmacy automation and pharmaceutical packaging to reimbursement and pharmaceutical consulting services. With more than $66 billion in annual revenue, AmerisourceBergen is headquartered in Valley Forge, PA, and employs more than 11,500 people. AmerisourceBergen is ranked #29 on the Fortune 500 list. For more information, go to www.amerisourcebergen.com.
This news release may contain certain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may vary materially from the expectations contained in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in any forward-looking statements: competitive pressures; the loss of one or more key customer or supplier relationships; customer defaults or insolvencies; changes in customer mix; supplier defaults or insolvencies; changes in pharmaceutical manufacturers' pricing and distribution policies or practices; adverse resolution of any contract or other disputes with customers (including departments and agencies of the U.S. Government) or suppliers; regulatory changes (including increased government regulation of the pharmaceutical supply channel); government enforcement initiatives (including (i) the imposition of increased obligations upon pharmaceutical distributors to detect and prevent suspicious orders of controlled substances (ii) the commencement of further administrative actions by the U. S. Drug Enforcement Administration seeking to suspend or revoke the license of any of the Company's distribution facilities to distribute controlled substances, (iii) the commencement of any enforcement actions by any U.S. Attorney alleging violation of laws and regulations regarding diversion of controlled substances and suspicious order monitoring), or (iv) the commencement of any administrative actions by the board of pharmacy of any state seeking to suspend, revoke or otherwise restrict the ability of any of the Company's distribution facilities or businesses to distribute or dispense pharmaceuticals in such state; changes in U.S. government policies (including reimbursement changes arising from federal legislation, including the Medicare Modernization Act and the Deficit Reduction Act of 2005); changes in regulatory or clinical medical guidelines and/or reimbursement practices for the pharmaceuticals we distribute, including erythropoiesis-stimulating agents (ESAs) used to treat anemia patients; price inflation in branded pharmaceuticals and price deflation in generics; fluctuations in market interest rates; operational or control issues arising from the Company's outsourcing of information technology activities; success of integration, restructuring or systems initiatives; fluctuations in the U.S. dollar - Canadian dollar exchange rate and other foreign exchange rates; economic, business, competitive and/or regulatory developments in Canada, the United Kingdom and elsewhere outside of the United States; acquisition of businesses that do not perform as we expect or that are difficult for us to integrate or control; any disruption to or other adverse effects upon the PMSI workers' compensation business caused by the Company's announcement that it is pursuing the sale of PMSI; the inability of the Company to successfully complete the sale of PMSI; the inability of the Company to successfully complete any other transaction that the Company may wish to pursue from time to time; changes in tax legislation or adverse resolution of challenges to our tax positions; and other economic, business, competitive, legal, tax, regulatory and/or operational factors affecting the business of the Company generally. Certain additional factors that management believes could cause actual outcomes and results to differ materially from those described in forward-looking statements are set forth (i) in Item 1A (Risk Factors) in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2007 and elsewhere in that report and (ii) in other reports filed by the Company pursuant to the Securities Exchange Act of 1934.