Study Suggests Asthma Medication Xolair Increases Heart Disease Risk
July 16, 2009
Intermin data from a study submitted to the FDA by Genentech, makers of the asthma drug Xolair (omalizumab) “suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug“, according to an FDA statement.
Nature & Health Co. Recalls Six Male Enhancement Products Marketed as Dietary Supplements
July 16, 2009
Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company’s five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
Brookstone Pharmaceuticals Recalls All Lots of Concentrated Acetaminophen Drops
July 15, 2009
Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Brookstone has distributed 344 bottles nationally and has donated 5301 bottles to charity for international distribution.
Haloteco Recalls Libipower Plus Dietary Supplement
July 14, 2009
Los Angeles, CA – Haloteco announced today that it is conducting a nationwide voluntary recall of the company’s product sold under the name Libipower Plus.
Covidien Recalls Sodium Chromate Cr-51 Injection, Lot #370-9004
July 11, 2009
Covidien announced that its Mallinckrodt Inc. subsidiary is voluntarily recalling one lot of Mallinckrodt Sodium Chromate Cr-51 Injection, lot #370-9004 as a result of routine post-market testing in which the product was found to be subpotent.
Medtronic Voluntarily Recalls Specific Lots of Paradigm® Quick-Set® Infusion Sets In The United States
July 1, 2009
UPDATED URL > Click Here for information on the Medtronic Paradigm Quick Set Infusion Set Recall
Hi-Tech Pharmaceuticals Recalls All Lots of Stamina-Rx Dietary Supplement Products
June 17, 2009
Norcross, GA – Hi-Tech Pharmaceuticals, Inc. (”Hi-Tech”), 6015-B Unity Dr., Norcross, GA 30071, announced today that it is conducting a nationwide voluntary recall of the company’s product sold under the name Stamina-Rx.
Zicam Recall Information
June 16, 2009
UPDATE: A Zicam recall is being conducted voluntarily by Matrixx, makers of Zicam Cold Remedy products.
FDA is warning consumers about certain Zicam products and a troubling potential side effect: loss of sense of smell.
FoodScience Corporation Recalls Kid’s Multivitamin for Label Error
June 10, 2009
FoodScience Corporation of Essex Junction, Vermont 05452 is voluntarily recalling a total of approximately 1,250 bottles of its Children’s Multi Vitamins.
Fun Express Expands Recall of Water-Based Face Paint
June 4, 2009
Fun Express, Inc. has expanded its May 12, 2009 recall of face paint items to include two additional face paint colors. The face paints may cause skin irritation, rashes and itchiness. The additional two face paint items are being removed from the marketplace as a precautionary measure.
Roche Diagnostics notifies customers of the potential for ACCU-CHEK Softclix 10 and/or 17 count lancets to be uncapped which may lead to an accidental needle stick
June 4, 2009
AS Medications Solution Recalls All Lots of Digoxin Tablets 0.25mg Due to Size Variability
June 4, 2009
A S Medication Solutions, LLC, a drug repackage company, announced that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin.
Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to Nationwide Recall
June 4, 2009
See this article for more information on the nationwide Hydroxycut product recall.
Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test
June 4, 2009
Fun Express Expands Nationwide Recall of Water-Based Face Paint
May 23, 2009
CONTACT: ANGELA D. DREW 402-596-2647
FUN EXPRESS, INC. HAS EXPANDED ITS MAY 12, 2009 RECALL OF FACE PAINT ITEMS TO INCLUDE TWO ADDITIONAL FACE PAINT COLORS. THE FACE PAINTS MAY CAUSE SKIN IRRITATION, RASHES AND ITCHINESS. THE ADDITIONAL TWO FACE PAINT ITEMS ARE BEING REMOVED FROM THE MARKETPLACE AS A PRECAUTIONARY MEASURE.
FDA Alerts Consumers to Recall of Water-Based Face Paints
May 13, 2009
THE FOOD AND DRUG ADMINISTRATION IS ADVISING CONSUMERS TO STOP USING CERTAIN COSMETIC “FACE PAINT” ITEMS LABELED AS DISTRIBUTED BY ORIENTAL TRADING CO., OMAHA, NEB., DUE TO ADVERSE EVENT REPORTS OF SKIN REACTIONS IN CHILDREN. THESE ITEMS WERE DISTRIBUTED NATIONWIDE.
Iovate Health Sciences Adds Hydroxycut-Branded Product Universal Product Codes to Recall
May 10, 2009
CONTACT: JAMIE MOSS 201-493-1027
IOVATE HEALTH SCIENCES USA, INC. OF BLASDELL, NEW YORK AND ONTARIO, CANADA ANNOUNCED TODAY THAT IT IS ADDING UNIVERSAL PRODUCT CODES (UPCS) WITH RESPECT TO THE RECALLED HYDROXYCUT-BRANDED PRODUCTS SOLD IN THE UNITED STATES. THESE ADDITIONS ALL INVOLVE ADDITIONAL PACKAGES AND SIZES OF PRODUCTS PREVIOUSLY REFERENCED.
Biosite Incorporated Recalls Cardiac Marker Test
May 7, 2009
CONTACT: CARMEN BERGELIN (858) 805-2256
Iovate Health Sciences U.S.A., Inc. Recalls Hydroxycut Products
May 5, 2009
CONTACT: JAMIE MOSS 201-493-1027
IOVATE HEALTH SCIENCES USA, INC. OF BLASDELL, NEW YORK AND ONTARIO, CANADA ANNOUNCED TODAY THAT IT IS VOLUNTARILY RECALLING HYDROXYCUT BRANDED PRODUCTS SOLD IN THE UNITED STATES.
Disetronic Medical Systems Recalls ACCU-CHEK Spirit Insulin Pumps
May 1, 2009
CONTACT: JULIE VINCENT 317-521-1910
FOR IMMEDIATE RELEASE — APRIL 30, 2009 — THIS NOTIFICATION APPLIES TO ALL ACCU-CHEK® SPIRIT INSULIN PUMPS WITH SERIAL NUMBERS FROM SN02119552 THROUGH SN10006093 (RANGE OF SN SHIPPED TO THE US). PUMPS WITH SERIAL NUMBERS INCLUDING AND ABOVE SN10006094 ARE NOT AFFECTED AND NO ACTION IS REQUIRED BY USERS OF THESE PUMPS.
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