Tag Archives: FDA

FDA: ETHEX Recalls Dextroamphetamine Sulfate 5mg Tablets

ETHEX Corporation has recalled three lots of dextroamphetamine sulfate 5mg tablets which may contain oversized pills and up to twice the dose of the drug. ETHEX discovered a small number of oversized tablets in lots that had not yet been distributed.  While there have been no reports of oversized tablets from consumers, Ethex is recalling three lots of the drug as a precaution. The round, orange tablets have ETHEX on one side and 311 on the other.  Lots being recalled are numbers 77946, 81141 and 81142.

Jalapeno Pepper Genetic Match for Salmonella Strain

The FDA announced yesterday, July 21, 2008, that they have traced the Salmonella SaintPaul strain that has caused a widespread outbreak of gastrointestinal illness in nearly 1,300 identified people in 43 states.  A sample of jalapeno pepper found in a produce distribution center in McAllen, Texas, is a genetic match for the Salmonella SaintPaul responsible for the outbreak.

Deaths from Salmonella Outbreak Continue to Rise

More than 810 cases of salmonella related to tomatoes have been reported to the FDA, according to the latest update on June 27th. Ninety-five people have been hospitalized.  Cases have been identified in 36 states and the District of Columbia.  While there have not been any confirmed deaths so far, there is one case of a man with cancer who died while infected and salmonellosis may have contributed to his death. Plum, Roma, and round red tomatoes have been associated with the particular strain of Saintpaul Salmonella infection.   The FDA is advising consumers eat these types of tomatoes only if they can be certain they were grown and harvested in

FDA Warns of Online Cancer Fraud

The FDA has developed a message for consumers warning them of fraudulent online cancer cures. They are frequently offered as dietary supplements or natural treatments. Medicines and devices intended to treat cancer must gain FDA approval before they are marketed. The agency’s review process helps ensure that these products are safe and effective.  Without such approval, no product can be marketed as a medical treatment. According to the FDA, many of these fraudulent cancer products may appear completely harmless, but can cause harm by delaying or interfering with proven, beneficial treatments.

Ethex Recalls Additional Lots of Both 30 mg and 60 mg Morphine Tablets

Ethex Corporation has expanded their voluntary recall of morphine sulfate tablets to both 30 mg and 60 mg doses and additional lots of both doses.  We reported a previous recall of a single lot of 60 mg tablets on June 11, 2008.  There is a potential problem that some tablets may be oversized and may contain as much as twice the dose of morphine on the label. No oversized tablets have been found in any of the additional lots now being recalled, but because the problem discovered in one lot, Ethex is taking extra precautions to ensure patient safety. The 60 mg tablet is a white oval with “60″ on

Ethex morphine tablets recalled

The FDA has announced a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets by Ethex Corporation. Lot No. 91762, distributed between April 16th and April 27th of 2008, contained at least one over-sized tablet that might contain up to twice the amount of morphine. While no reports of serious effects from Ethex morphine tablets have been reported, the opioid medicines are being recalled to prevent life-threatening overdoses. Extended release morphine is often used to manage cancer pain, particularly in patients with advanced disease.  Since many of these patients are already weak, it might be difficult for them to recognize an over-sized pill. Signs of

FDA Approves Entereg to Improve Post-Surgery Bowel Function

The FDA has approved Entereg® (alvimopan) to speed the restoration of normal bowel function after intestinal surgery. However, the approval comes with a Risk Evaluation and Mitigation Strategy (REMS) to be sure that the benefits of using Entereg outweigh any potential risks.  Under the REMS, the drug can only be used only in hospitals for inpatients.  Hospitals that use it must be certified and materials developed for the health care professionals who administer it.  Its effectiveness must be regularly assessed.