NDC #58177-320-04 & 58177-330-04 Lot Numbers listed below
ST. LOUIS, June 13 /PRNewswire/ -- ETHEX Corporation announced today that
it has voluntarily recalled specific additional lots of morphine sulfate 60 mg
extended release tablets, and specific lots of morphine sulfate 30 mg extended
release tablets, as a precaution, due to the possible presence of oversized
tablets. Oversized tablets may contain as much as two times the labeled level
of active morphine sulfate. The recalled lots were distributed by ETHEX
Corporation under an "ETHEX" label between June 2006 and May 2008. The lot
numbers involved in the recall are:
Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04: Lots 75090, 77846,
77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284
Morphine Sulfate ER 60mg Tablet/NDC # 58177-330-04: Lots 91762
(previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333,
83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through
86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272,
and 91763 through 91765.
No report of unexpected side effects or injury has been received.
However, opioids such as morphine, have life-threatening consequences if
overdosed. Those consequences can include respiratory depression (difficulty
or lack of breathing), and low blood pressure, apnea, and hypotension.
The voluntary recall follows a report that a tablet with as much as double
the appropriate thickness was identified in a previously recalled lot. No
oversized tablets have been identified in any additional distributed lot of
these products and, based on our investigation, there are likely to be few, if
any, oversized tablets in the recalled lots. The decision to recall the
additional lots listed above has been taken as a responsible precaution
because of the possibility that there may be oversized tablets in those lots.
The 60 mg product is a white oval tablet with "60" on one side, and "E" on
the reverse. The 30 mg product is a pink oval tablet with "30" on one side,
and "E" on the reverse.
Any customer inquiries related to this action should be addressed to ETHEX
Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at
314-646-3751 or sent via email to: customer-service@ethex.com with
representatives available Monday through Friday, 8 am to 5 pm CDT.
ETHEX Corporation has initiated recall notifications to wholesalers and
retailers who have received any inventory of the recalled lots of this product
with instructions for returning the recalled product and, if they have not
already done so, they are urged to contact the number above regarding
procedures for returning the recalled product. If consumers have any
questions about the recall, they should call the number above, their
physician, their pharmacist or other health care provider.
This recall is being conducted with the knowledge of the Food and Drug
Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or
quality problems may also be reported to the FDA's MedWatch Program by phone
at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600
Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at
www.fda.gov/medwatch.
Safe Harbor
The information in this release may contain various forward-looking
statements within the meaning of the United States Private Securities
Litigation Reform Act of 1995 ("PSLRA") and which may be based on or include
assumptions concerning KV's operations, future results and prospects. Such
statements may be identified by the use of words like "plans", "expect",
"aim", "believe", "projects", "anticipates", "commit", "intend", "estimate",
"will", "should", "could" and other expressions that indicate future events
and trends.
All forward-looking statements are based on current expectations and are
subject to risk and uncertainties. In connection with the "safe harbor"
provisions, KV provides the following cautionary statements identifying
important economic, competitive, political and technology factors, which among
others, could cause actual results or events to differ materially from those
set forth or implied by the forward-looking statements and related
assumptions.
Such factors include (but are not limited to) the following: (1) changes
in the current and future business environment, including interest rates and
capital and consumer spending; (2) the difficulty of predicting FDA approvals,
including timing, and that any period of exclusivity may not be realized; (3)
acceptance and demand for new pharmaceutical products; (4) the impact of
competitive products and pricing, including as a result of so-called
authorized-generic drugs; (5) new product development and launch, including
the possibility that any product launch may be delayed or that product
acceptance may be less than anticipated; (6) reliance on key strategic
alliances; (7) the availability of raw materials and/or products manufactured
for the Company under contract manufacturing arrangements with third parties;
(8) the regulatory environment, including regulatory agency and judicial
actions and changes in applicable law or regulations; (9) fluctuations in
revenues; (10) the difficulty of predicting international regulatory approval,
including timing; (11) the difficulty of predicting the pattern of inventory
movements by the Company's customers; (12) the impact of competitive response
to the Company's sales, marketing and strategic efforts; (13) risks that the
Company may not ultimately prevail in litigation; (14) completion of the
Company's financial statements for the first, second and third quarters of
fiscal 2008 and for the full fiscal year ended March 31, 2008; (15) actions by
the Securities and Exchange Commission and the Internal Revenue Service with
respect to the Company's stock option grants and accounting practices; (16)
KV's current belief that the recall described above will not have material
impact on KV's financial condition or results of operation could prove to be
incorrect; (17) whether any of the recalled product results in litigation,
agency action or material damages; and (18) the risks detailed from
time-to-time in the Company's filings with the Securities and Exchange
Commission.
SOURCE ETHEX Corporation
