June 25, 1999
Schein Pharmaceutical Takes Further
Steps at Marsam Subsidiary
Florham Park, NJ (SafetyAlerts) - Schein Pharmaceutical,
Inc. (NYSE:SHP) announced today that its subsidiary, Marsam Pharmaceuticals Inc., has
expanded its voluntary product recall to include all remaining Marsam products within
"We are taking this further action in part to
underscore to the Food and Drug Administration (FDA) that Schein Pharmaceutical and Marsam
have begun, and are fully prepared to continue, initiating and executing actions
expeditiously to address the regulatory agency's concerns at the Marsam facility,"
noted Martin Sperber, chairman and chief executive officer of Schein Pharmaceutical.
"By recalling all Marsam products, even before our review of them is completed, and
submitting to the FDA a list of principal points that would be detailed in a corrective
action plan, we are taking steps to actively demonstrate our commitment to
The FDA inspection is ongoing and additional
actions by Marsam and the FDA are expected in connection with the inspection.
Marsam contributed approximately seven percent of
the Company's revenues and a smaller percentage of its gross profits over the last four
The Company also announced that it has entered
into a contract manufacturing agreement to secure for the remainder of the year supply of
one of its more significant cephalosporin products manufactured by Marsam.
Schein Pharmaceutical, Inc. has a diverse
portfolio of both branded and generic products. Schein Pharmaceutical integrates its
product development expertise, diverse, high-volume production capacity and direct sales
and marketing force to capitalize on the commercialization of products. The Company's
brand products group has developed an expertise in the management of anemia in nephrology,
and is looking to expand this expertise to iron management in hematology, oncology, and
gastroenterology. The group's current product portfolio now consists of Ferrlecit®, as
well as INFeD®, which is currently the leading injectable iron product in the United
States. In addition, the Company develops, manufactures and markets a broad generic
product line including both solid and sterile dosage products. The Company has a
substantial pipeline of products under development, and enhances its internal product
development, manufacturing and marketing capabilities through strategic collaborations.
Schein Pharmaceutical operates manufacturing facilities in Arizona, Connecticut, New
Jersey, New York and Puerto Rico.
Certain of the matters discussed in this press
release contain statements concerning future events or results. These "forward
looking" statements involve certain significant risks and uncertainties, and actual
results may differ materially from the forward looking statements. Some important factors
which may cause results to differ include: the uncertainty and the difficulty of
predicting FDA approvals, uncertainties associated with the implementation of the terms
and conditions of the consent decree affecting the Steris facility, the uncertainty of the
outcome of the ongoing inspection by the FDA at the Company's Marsam facility, the
uncertainty of acceptance and demand for the Company's new products, the impact of
competitive products and pricing, the availability of raw materials, uncertainties
associated with litigation and regulatory matters, and fluctuations in operating results.
For further details and discussion of these risks and uncertainties see Schein
Pharmaceutical, Inc.'s SEC filings including, but not limited to, its annual report on
Form 10-K and its quarterly report on Form 10-Q for the quarter ended March 27, 1999. The
Company does not undertake to publicly update or revise any of its forward looking
statements even if experience or future changes show that the indicated results or events
will not be realized.
Contact: Melody A. Carey, Investor Relations
Telephone: (973) 593-5535
Fax: (973) 593-5598