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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

VALLEY FORGE, Pa. -- American Health Packaging (AHP AHP Assistant House Physician. ), a subsidiary of AmerisourceBergen Corporation (NYSE NYSE

See: New York Stock Exchange
:ABC ABC
 in full American Broadcasting Co.

Major U.S. television network. It began when the expanding national radio network NBC split into the separate Red and Blue networks in 1928.
), today announced a voluntary recall of 1,421 units (25 vials per unit) of 10000 USP USP - unique sales point  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 (Switched Digital Video) See switched video.  25UD (bag) NDC NDC National Drug Code
NDC NATO Defense College
NDC National Documentation Centre (National Hellenic Research Foundation, Athens, Greece)
NDC National Dairy Council
NDC National Democratic Congress
 # 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 dyspepsia: see indigestion. , dyspnia, erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. , flushing, headache, hyperhidrosis, hypoesthesia hypoesthesia /hy·po·es·the·sia/ (-es-the´zhah) abnormally decreased sensitivity, particularly to touch.hypoesthet´ic

hy·po·es·the·sia or hy·pes·the·sia
n.
, hypotension hypotension
 or low blood pressure

Condition in which blood pressure is abnormally low. It may result from reduced blood volume (e.g., from heavy bleeding or plasma loss after severe burns) or increased blood-vessel capacity (e.g., in syncope).
, including profound and refractory hypotension, increased lacrimation lacrimation /lac·ri·ma·tion/ (lak?ri-ma´shun) secretion and discharge of tears.

lac·ri·ma·tion or lach·ry·ma·tion
n.
The secretion of tears, especially in excess.
, loss of consciousness, malaise, nausea, pallor pallor /pal·lor/ (pal´er) paleness, as of the skin.

pal·lor
n.
Paleness, as of the skin.
, palpitations, paresthesia paresthesia /par·es·the·sia/ (par?es-the´zhah) morbid or perverted sensation; an abnormal sensation, as burning, prickling, formication, etc.

par·es·the·sia or par·aes·the·sia
n.
, paresthesia (oral), pharyngeal pharyngeal /pha·ryn·ge·al/ (fah-rin´je-al) pertaining to the pharynx.

pha·ryn·geal or pha·ryn·gal
adj.
Of, relating to, located in, or coming from the pharynx.
 adema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus trismus /tris·mus/ (triz´mus) motor disturbance of the trigeminal nerve, especially spasm of the masticatory muscles, with difficulty in opening the mouth (lockjaw); a characteristic early symptom of tetanus. , 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.

About AmerisourceBergen

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.

FORWARD-LOOKING STATEMENTS

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 The Drug Enforcement Administration (DEA) was established in 1973 by President richard m. nixon as part of the Justice Department, thus uniting a number of federal drug agencies that had often worked at cross-purposes.  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 PMSI Purchase-Money Security Interest (generally a lien resulting from a purchase such as a car loan)
PMSI Physician Micro Systems, Inc.
PMSI Programme de Médicalisation des Systèmes d'Information Hospitaliers
PMSI Popular Mortgage Servicing, Inc.
 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.
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Publication:Business Wire
Date:Mar 20, 2008
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