Center for Devices and Radiological Health

A retrospective cohort study reports small increase in risk of cardiovascular deaths and risk of all cause deaths associated with 5 day course of antibiotic drug

UPDATED 05/14/2012. New recommendations for monitoring patients, and new contraindications, and dosing & administration information for use in certain patients.

An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

UPDATED 05/07/2012. Increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma in patients being treated with Revlimid.

[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.

UPDATED 04/26/2012. Label revised to state that co-administration of Victrelis with certain ritonavir-boosted human immunodeficiency virus protease inhibitors is not recommended. Originally posted 02/09/2012

Undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.

Customers should immediately discontinue use of any affected product.

[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.

Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes.

Exposure to contaminated product may lead to serious infections.

Consequences of opioid pain medication overdose can be life-threatening, including respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

Availability of FDA Publications Translated into various Languages

• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. • The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores. • The company name and Nakaochi Scrape AA or AAA were printed on boxes of the product when it was initially sold to distributors. However, the boxes may have been broken into smaller lots for further sale and may not be available to the end retailer or consumer. Therefore, the tuna may not be readily identifiable by retail outlets or by consumers as being from the implicated lots. • The Nakaochi Scrape AA and AAA from MMI was sold through distributors to restaurants and grocery stores that make sushi, and has been linked to an outbreak of Salmonella Bareilly, which has caused 116 illnesses in 20 states and the District of Columbia to date. Of the reported illnesses, there have been 12 hospitalizations, and no deaths. • Many of the people who became ill reported eating raw tuna in sushi as “spicy tuna.” • If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation, also known as MMI. When in doubt, don’t eat it. • Consumers who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape should consult their health care providers.

Harry and David, is voluntarily recalling approximately 205 2 oz. bags labeled Harry & David Premium Kansas City Style Barbeque almonds, because the bags may contain peanuts. Peanuts are not declared as ingredients, but the label includes the statement "May contain trace amounts of allergens not listed in the ingredients." 

Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores.

Mission Foods announced today a voluntary recall of its Taco Dinner Kits distributed by Kroger, Winn-Dixie, Hannaford and Food Lion because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.