The FDA has announced that the ETHEX Corporation has voluntarily recalled five generic, non-branded products. ETHEX has taken this step as a precaution, for the drugs may contain oversized tablets. Oversized tablets can cause a drug overdose because they contain more than the intended levels of the active ingredient. This could result in the patient receiving as much as double the expected dosage of the drug.
Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.
The current recall pertains to the following drugs:
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. Tablets are white tablet with “ETH” on one side and “331″ on the reverse.
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. Tablets are white, with “ETH” on one side and “332″ on the reverse.
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. Tablets are white, with “ETH” on one side and “333″ on the reverse.
Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009. Tablets are an oval, reddish-pink tablet, with a debossed “E” “30″ on one side and bisect on the other side.
Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009. Tablets are an oval, yellow tablet with a debossed “E” “60″ on one side and bisect on the other side.
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. Tablet is a green oval tablet with “15″ on one side and an “E” on the reverse.
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. Tablet is a round brown tablet with a “15″ on one side and an “ETH” on the reverse.
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. Tablet is a capsule shaped brown tablet with “30″ on one side and an “ETHEX” on the reverse.
Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011. Tablets are a round, orange mottled tablet debossed “ETHEX” and “312″ on one side and double-scored on the other side.
Recall notifications have been issued to all ETHEX wholesalers and retailers who were shipped any inventory of the recalled lots. These notifications include instructions for returning the recalled products and instructions for retailers and/or pharmacies to contact consumers who were issued these drugs for replacement and/or refund.
Wholesalers and retailers are urged to contact ETHEX Customer Service at 1-800-748-1472 in regards to procedures for returning the recalled products. Also, if consumers have any questions about the recall they should call ETHEX Customer Service, their physician, and pharmacist or any other health care provider. Consumers, wholesalers and retailers can also fax to EHEX Customer Service at 314-646-3751 or email customer-service@ethex.com. Representatives are available Monday through Friday 8:00 AM to 5:00 PM CST.
Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.
The ETHEX Corporation recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Customers, wholesalers or retailers may also contact 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 in regards to any adverse reactions experienced with the use of these products, or any other problems.
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If you or a loved one have experienced an adverse event or serious side effect you should also contact a drug side effects or drug recall attorney immediately. You may be entitled to compensation for your injuries and we can help. Please use the form below for a free case evaluation.
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