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.
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 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.
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