St. Louis, MO- November 7, 2008 – ETHEX
Corporation announced today that it has voluntarily recalled to the consumer
level specific lots of five generic /non-branded products that it markets. These
lots have been recalled as a precaution, due to the possibility that they may
contain oversized tablets. Oversized tablets may contain more than the
intended levels of the active drug ingredient, which could result in patients
receiving as much as about twice the expected dosage of these drugs.
Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and
Dextroamphetamine Sulfate can have serious or life-threatening consequences. In
the case of Propafenone HCl, these consequences can include arrhythmias (irregular
heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate,
these consequences can include fainting and low blood pressure. In the
case of Morphine Sulfate, these consequences can include respiratory depression
(difficulty or lack of breathing) and low blood pressure. In the case
of Dextroamphetamine Sulfate, these consequences can include rapid heart rate
and high blood pressure.
The lots involved in the recall were all shipped prior to May 22, 2008 and
are as follows:
Propafenone HCl Tablets, 150 mg: Lots: 73761,
78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with
expiration dates ranging from 3/2009 to 3/2011
Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15,
81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009
to 2/2011
Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246,
89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from
6/2009 to 3/2011
Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355,
66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009
Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466,
66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009
Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175,
82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging
from 12/2008 to 2/2010
Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54,
81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009
to 1/2011
Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093,
77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates
ranging from 8/2009 to 3/2011
Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934,
75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011
The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film
coated tablet with "ETH" on one side and "331" with
a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets
is a white, scored round film coated tablet with "ETH" on one side
and "332" with a bisect on the reverse. The 300 mg Propafenone
Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on
one side and "333" with a bisect on the reverse.
The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink,
film-coated tablet with a debossed "E" bisecting "30" on
one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended
Release Tablet is an oval, yellow film-coated tablet with a debossed "E" bisect "60" on
one side and bisect on the other side.
The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet
with "15" on one side and an "E" on the reverse. The
15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with
a "15" on one side and an "ETH" on the reverse. The
30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet
with "30" on one side and an "ETHEX" on the reverse.
The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge,
orange mottled tablet debossed "ETHEX" and "312" on
one side and double-scored on the other side.
ETHEX Corporation has initiated recall notifications to wholesalers and retailers
who have received any inventory of the recalled product lots with instructions
for returning the recalled products. The notification also includes instructions
for the retailers/pharmacies to contact consumers who were dispensed these
drugs for replacement of the product and/or refund. If the wholesalers
and retailers have not already done so, they are urged to contact the number
below regarding procedures for returning the recalled products. If
consumers have any questions about the recall, they should call the number
listed below for customer inquiries, their physician, their pharmacist or other
health care provider.
Consumers who experience any adverse reactions to these drugs should contact
their physician and/or healthcare provider immediately.
Any customer inquiries related to this action should be addressed to ETHEX
Customer Service at 1-800-748-1472, 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, 8:00 am to 5:00 pm Central
Standard Time (CST).
This recall is being conducted with the knowledge of the U.S. Food and Drug
Administration (FDA).
Any adverse reactions experienced with the use of these products, 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.
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