The ETHEX Corporation has recently announced a voluntarily recall of five specific lots of generic products that it currently markets. These lots may contain possibly hazardous oversized tablets, and as a result, a recall is being undertaken as a precaution. Oversized tablets pose certain health risks, as they can contain excess levels of the active drug ingredient. Ingesting such tablets could result in patients consuming up to nearly twice the expected dosage of the drugs.
The lots that are the subject of this recall were all shipped before May 22, 2208. These lots include:
Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from March, 2009 to March, 2011. An overdose of this drug can have serious and/or life-threatening consequences, which may include irregular heartbeat (arrhythmias), and decreased blood pressure. These tablets are white and have a coated, scored round film with “ETH” on one side and “331″ with on the other.
Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from March, 2009 to February, 2011. These tablets look very similar to the Propafenone 150 mg tablets, except they read “332” on the side opposite the “ETH” letters. These tablets have the same health consequences explained for the Propafenone 150 mg tablets.
Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from June, 2009 to March, 2011. These tablets are, again, white with a coated, scored round film. The letters “ETH” on one side and on the 300 mg tablet, “333″ appears on the reverse. These tablets have the same health consequences explained for the Propafenone 150 mg tablets.
Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from November, 2008 to August, 2009. Ingestion of these oversized tablets may result in fainting and/or low blood pressure. These tablets are oval and film colored with a reddish-pink color. An “E” dividing “30″ appears on one side, with a bisect on the other.
Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from December, 2008 to November, 2009. Theses tablets are oval and film-coated, are yellow in color and include an “E” dividing “60″ on one side and bisect on the other. These tablets have the same health consequences explained for the Isosorbide 30 mg tablets.
Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from December, 2008 to February, 2010. An overdose of the drugs contained in these tablets can have serious or life-threatening consequences. Such consequences can include respiratory depression characterized by difficulty or lack of breathing and low blood pressure. These tablets are green and oval with a “15″ on one side and an “E” on the other.
Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from September, 2009 to January, 2011. These tablets are round and brown colored and contain a “15″ on one side and an “ETH” on the other. These tablets have the same health consequences explained for the Morphine Sulfate 15 mg tablets.
Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from August, 2009 to March, 2011. These tablets are capsule shaped and brown colored, and contain a “30″ on one side and an “ETHEX” on the other. These tablets have the same health consequences explained for the Morphine Sulfate 15 mg tablets.
Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from June, 2009 to May, 2011. An overdose of this drug can have serious and life-threatening consequences, such as rapid heart rate and high blood pressure. These tablets are round, flat-faced, bevel edged, orange-colored mottled tablets with “ETHEX” and “312″ on one side and are double-scored on the other.
ETHEX Corporation has sent recall notifications to both retailers and wholesalers who have received any inventory of the recalled lots. This notification provides instructions to return the drugs, and also includes instructions for the retailers/pharmacies to contact the consumers who received these drugs for replacement and/or refund of the product. If consumers have any questions about this recall, they should contact their physician, their pharmacist or other health care provider, and strongly consider obtaining the guidance of legal counsel to preserve their legal rights to the extent they exist.
Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately. Affected consumers should also immediately contact an attorney as damages may be recoverable.
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