Description
FOR IMMEDIATE RELEASE -- St. Louis, MO – June 13, 2008 – 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.