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.
Nature and Health Recalls Libimax Because it Contains Pharmacutical Ingredients for Erectile Dysfunction
April 30, 2009
CONTACT: BOKSIK (AKA ROBERT) KIM (714) 257-1800
Personal Care Products Conducts Nationwide Recall of Non-Acetone Nail Polish Remover
April 30, 2009
CONTACT: LAWRENCE WEISBERG 248-258-1555
FOR IMMEDIATE RELEASE — APRIL 29, 2009 — PERSONAL CARE PRODUCTS OF BINGHAM FARMS, MI IS VOLUNTARILY CONDUCTING A NATIONWIDE RECALL OF ALL LOTS OF PERSONAL CARE NON-ACETONE NAIL POLISH REMOVER, CONDITIONER ENRICHED WITH GELATIN, 6 FL. OZ., UPC 4815592076, BECAUSE IT DOES NOT MEET PRODUCT SPECIFICATIONS AND HAS THE POTENTIAL TO CAUSE CHEMICAL BURNS TO THE FINGERS OF USERS.
Recall Of Prescription Cough and Cold Drugs by Neilgen Pharma and Advent Pharmaceutical
April 22, 2009
CONTACT: BHARAT PATEL, PRESIDENT (609) 448-5500
NEILGEN PHARMA INC. OF WESTMINSTER, MD AND ADVENT PHARMACEUTICAL OF EAST WINDSOR, NJ ARE RECALLING ALL PRESCRIPTION COUGH AND COLD DRUG PRODUCTS SOLD ON OR AFTER MARCH 5, 2008. NEILGEN PHARMA AND ADVENT PHARMACEUTICAL ARE CONTRACT MANUFACTURERS FOR THESE PRODUCTS AND ARE RECALLING THE LISTED PRODUCTS BELOW DUE TO THE UNAPPROVED DRUG PRODUCT CATEGORY.
Arrow International Announces Worldwide Voluntary Recall of Intra Aortic Balloon Pump (IAB) Catheters
April 17, 2009
TELEFLEX MEDICAL ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS CLASSIFIED THE VOLUNTARY MEDICAL DEVICE RECALL INITIATED ON FEBRUARY 2, 2009 BY ARROW INTERNATIONAL’S CARDIAC CARE DIVISION INVOLVING VOLUME CONNECTORS FOR ITS 30CC, 40CC AND 50CC INTRA AORTIC BALLOON PUMP (IAB) CATHETERS AS A CLASS 1 RECALL. FDA DEFINES CLASS I RECALLS AS, “A SITUATION IN WHICH THERE IS A REASONABLE PROBABILITY THAT THE USE OF OR EXPOSURE TO A VIOLATIVE PRODUCT WILL CAUSE SERIOUS ADVERSE HEALTH CONSEQUENCES OR DEATH.” THIS RECALL IS BEING CONDUCTED BECAUSE A FAULT IN THE CONNECTOR OF THE PUMP TUBING ASSEMBLY MAY RESULT IN THE VOLUME SETTING ON THE PUMP DEFAULTING TO 2.5 CC OR 5 CC, RATHER THAN THE APPROPRIATE 30, 40, OR 50 CC VOLUME. IN PATIENTS EXHIBITING MODERATE TO SEVERE MYOCARDIAL ISCHEMIA OR LOW PERFUSION STATES, PROLONGED EXPOSURE TO THE LOW DEFAULT VOLUME MAY FAIL TO DECREASE ISCHEMIA AND INCREASE PERFUSION, LEADING TO ORGAN INJURY OR INFARCT AND MAY RESULT IN PATIENT DEATH. PROLONGED EXPOSURE TO A DEVICE WHICH IS INFLATED TO LESS THAN 2/3 FULL COULD ALSO RESULT IN THROMBUS FORMATION ON THE IAB AND POSSIBLE SUBSEQUENT SYSTEMIC OR CEREBRAL THROMBOEMBOLISM. INSTRUCTIONS CONTAINED IN THE OPERATOR’S MANUAL FULLY DESCRIBE THE NECESSARY WARNINGS AND PRECAUTIONS THAT WILL IDENTIFY THE ISSUE. THE RECALL NOTICE RESTATES THESE INSTRUCTIONS AND REFERENCES THE SECTIONS IN THE OWNER’S MANUAL. IF THESE INSTRUCTIONS ARE FOLLOWED, THE ISSUE FOR WHICH THE PRODUCT WAS RECALLED CAN BE DISCOVERED IMMEDIATELY, AND THE PRODUCT CAN BE REMOVED AND REPLACED. ARROW INTERNATIONAL NOTIFIED BOTH DOMESTIC AND FOREIGN HOSPITALS AND DISTRIBUTORS VIA AN URGENT MEDICAL DEVICE RECALL LETTER DATED FEBRUARY 2, 2009 THAT THE COMPANY HAD BECOME AWARE THAT THE BLUE CONNECTOR FOR THE 40CC IAB WAS NOT PROPERLY RECOGNIZED BY THE ARROW INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM. THIS RECALL INVOLVED THE RETRIEVAL OF UNUSED PRODUCT, ISSUANCE OF MITIGATION INSTRUCTIONS FOR PATIENTS AND/OR FACILITIES IN CRITICAL NEED, AND THE REPLACEMENT OF PUMP TUBING ASSEMBLIES. AT THIS TIME, THERE HAVE BEEN 25 COMPLAINTS OF THIS ISSUE. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY AS A RESULT OF THIS ISSUE. APPROX. 423 LOTS ARE AFFECTED BY THIS RECALL FOR A TOTAL 45,211 UNITS.
ION Labs Inc. Recalls Influend Cough and Cold Products, in Alabama
April 17, 2009
ION LABS INC. OF CLEARWATER, FL. IS VOLUNTARILY RECALLING ALL OF THE INFLUEND COUGH AND COLD PRODUCTS SOLD ON OR AFTER MAY 30, 2008. ION LABS INC. IS RECALLING THE LISTED PRODUCTS DUE TO THE PRODUCTS NOT TESTED IN CONFORMANCE WITH THE SPECIFICATIONS OF THE LAB, THEREFORE THE PRODUCTS MAY HAVE A POSSIBILITY TO BE SUPER POTENT. POSSIBLE COMPLICATIONS MAY INCLUDE TACHYCARDIA, PALPITATIONS, ARRHYTHMIAS, CARDIOVASCULAR COLLAPSE WITH HYPOTENSION, HEADACHES, DIZZINESS, ANXIETY, RESTLESSNESS AND NERVOUSNESS. THE FOLLOWING PRODUCTS WERE DISTRIBUTED AND SOLD DIRECTLY TO CONSUMERS IN THE MADISON/HUNTSVILLE, ALABAMA AREA:
ION Labs Inc. Recalls Influend Cough and Cold Products, in Alabama
April 16, 2009
CONTACT: 877-990-4466
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