The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose–80 milligram (mg)–has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.
Category Archives: Food & Drug Recalls
FDA: Pfizer will voluntarily suspend sale of animal drug 3-Nitro
The U.S. Food and Drug Administration today announced that Alpharma, a subsidiary of Pfizer Inc., will voluntarily suspend U.S. sales of the animal drug 3-Nitro (roxarsone), a product used by poultry producers since the 1940s.
US NUTRITION Issues Allergy Alert On Undeclared Fish In Daily Multible For Women 50 + Tablets
US Nutrition, of Ronkonkoma, New York is recalling Daily Multiple for Women 50 + Tablets, because certain lots contain undeclared Fish (fish gelatin). People who have an allergy or severe sensitivity to Fish run the risk of a serious or life-threatening allergic reaction if they consume these products.
FDA: DDS probiotic products seized
U.S. Marshals, at the request of the U.S. Food and Drug Administration, today seized probiotic products from UAS Laboratories, Inc., of Eden Prairie, Minn. because the company markets the products as drugs.
American Regent Initiates Nationwide Voluntary Recall of Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates
American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product: Methyldopate HCL Injection, USP, 250 mg/5 mL (50mg/mL), 5 mL Single Dose Vial NDC # 0517-8905-10, Lot # 0152, Exp Date March, 2012. PLEASE NOTE: This recall, initiated on June 6, 2011 to the User or Consumer Level, is for Lot # 0152 only.
MGA Recalls Item # 504788BRATZ MAKEUPDesign Sketch Book Because of Possible Health Risk
MGA Entertainment of Van Nuys, CA is recalling 6,200 units of the Bratz Makeup Design Sketch Book. This product has the potential to be contaminated with Staphylococcus warneri and Staphylococcus intermedius. MGA is recalling products produced between November 5, 2010 and February 25, 2011. MGA has ceased production and distribution of this product.
Voluntary Worldwide Field Correction Issued for the S98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps
In March 2011, Datascope Corp/Maquet initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT (Part numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx and 0998-UC-0479Hxx) and CS300 ( Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names. Customers who have 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT, CS100/CS100i and CS300 IABP brand names which are being recalled may schedule a visit by a Service Representative by contacting the US Call Center at 1-800-777-4222, Press 3.
Global Wellness, LLC Conducts a Nationwide Voluntary Recall of VIA XTREME ULTIMATE SEXUAL ENHANCER DIETARY SUPPLEMENT FOR MEN Due to Presence of Undeclared Drug
Global Wellness, LLC. Hollywood, FL is conducting a voluntary nationwide recall of VIA XTREME ULTIMATE SEXUAL ENHANCER DIETARY SUPPLEMENT FOR MEN to the consumer level. The product was distributed throughout the U.S. Puerto Rico, and Canada to internet and retail consumers.
Kashi Recalls Select Frozen Pizzas Because They May Contain Plastic Fragments
Kashi is recalling approximately 11,000 cases of frozen pizzas, including Mediterranean Thin Crust Pizza, Roasted Vegetable Thin Crust Pizza, and Mushroom Trio and Spinach Thin Crust Pizza due to possible plastic fragments in an ingredient in the pizza crusts. No other Kashi frozen pizzas or other products are included in the recall, and no consumer complaints have been reported. The products were distributed nationwide through U.S. retail grocery stores.
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Simply Thick, LLC Announces The Voluntary Recall Of Products Manufactured By Thermo Pac, LLC At Their Stone Mountain, GA Food Processing Plant
St. Louis, MO — Simply Thick, LLC is announcing a voluntary recall of its SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia since June 1, 2009. This plant is currently owned and operated by Thermo Pac, LLC. This voluntary recall is limited to only those products manufactured at the Stone Mountain, Georgia plant.