, Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
The U.S. Food and Drug Administration today announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.
FDA awards six grants for natural history studies in rare diseases
The U.S. Food and Drug Administration today announced it has awarded six new research grants for natural history studies in rare diseases. The aim of the research is to inform medical product development by better understanding how specific rare diseases progress over time. One potential application of these studies is the opportunity to eventually use natural history models to augment the need for placebo arms in studies of drugs that target very rare disease, where trial recruitment can be challenging.
FDA approves first test for screening Zika virus in blood donations
The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors.
Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures
Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing temperature is outside of the acceptable storage range listed on the product labeling. Other shipments of this lot are not affected by this issue.
Gadget Island, Inc. dba Gear Isle Issues Voluntary Nationwide Recall of Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000 and Grande X 5800, Due to Presence of Undeclared Sildenafil, Tadalafil and Desmethyl Carbodenafil
Newark, CA, Gadget Island, Inc. is voluntarily recalling Rhino 7 Platinum 5000 capsules, All LOTS, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level. FDA analysis has found the products to be tainted with Sildenafil and Tadalafil, which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED), as well as Desmethyl Carbodenafil which is structurally similar to sildenafil. The presence of Sildenafil, Tadalafil and or Desmethyl Carbodenafil in Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000, and Grande X 5800, renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Sid Wainer & Son® Initiates Class 1 Recall for Jansal Valley® Dried Chili De Arbol Peppers Due to Possible Health Risk
Sid Wainer & Son® of New Bedford, MA is voluntarily recalling Jansal Valley® brand Dried Chili De Arbol Peppers because it does not have the proper allergens identified, being peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Tai Foong Usa Issues Allergy Alert on Undeclared Egg in Product
TAI FOONG USA of Seattle, WA is recalling Royal Asia Shrimp Wonton Noodle Soup, because it may contain undeclared EGG. People who have an allergy or severe sensitivity to Egg or egg products run the risk of serious or life-threatening allergic reaction if they consume these products. Individuals who are not allergic to eggs may safely consume this product.
Dean Dairy Conducts Voluntary Recall of Tampico® Brand Tropical Punch in Illinois, Indiana and Wisconsin Because It May Contain Undeclared Allergen (Milk)
Impacts only the gallon-size Tropical Punch flavor of Tampico® bottled and distributed by Dean Dairy and sold in Illinois, Indiana and Wisconsin. All affected product has the “Best By” date of 12-27-17.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool