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U.S. Department of Health and Human Services

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Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg

Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets 15 mg
Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets 10 mg


Audience: Pharmacists, other healthcare professionals, patients

[UPDATE 01/28/2009] ETHEX Corporation issued a nationwide voluntary recall of products at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace.

[Posted 11/10/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets). The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences. Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's recall notice for specific lot numbers of the products affected by this recall.

[November 07, 2008 - Press Release - Ethex Corp]

Previous MedWatch Alert:

[October 16, 2008]