Important Information for Extavia (interferon beta 1-b) Patients Regarding Triad Group’s Alcohol Prep Products

February 1, 2011

Novartis Pharmaceuticals Corporation (Novartis) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus, that could potentially lead to life-threatening infections.

Some of these alcohol prep pads from Triad may have been included in U.S. packaging for Extavia, a product marketed by Novartis. The Triad alcohol prep pads should not be used.

Manna Pro Products Recalls Horse Feed Distributed in California, Nevada, and Oregon

January 30, 2011

Monensin sodium is a medication approved for use in some livestock and poultry species, but can be fatal to horses if fed at sufficiently high levels.
Manna Pro Products, LLC is voluntarily recalling a single lot (1006) of Family Farm Complete Horse 10 horse feed, UPC 0 95668 90151 6, packaged in 40 lb. bags because it may contain monensin sodium (Rumensin). Monensin sodium is a medication approved for use in some livestock and poultry species, but can be fatal to horses if fed at sufficiently high levels. The lot number (1006) can be found on the tag, below the bar code. Additionally, the code “MADE 010611W” will be printed on the white strip sewn across the bottom of the bag. This feed was distributed January 11, 2011 through January 21, 2011 to retailers in California, Nevada, and Oregon. Retailers receiving product from the lot in question have removed it from their stores. Initial testing has indicated the presence of a potentially harmful level of monensin sodium (Rumensin) in this single lot. Further follow up testing is underway. While no illnesses or deaths have been reported, out of an abundance of caution, customers who purchased Family Farm Complete Horse 10 from lot 1006 should stop feeding the product immediately. At this time, the limited voluntary recall only applies to Family Farm Complete Horse 10, lot 1006. No other Manna Pro or Family Farm products and no other lots of Complete Horse 10 are involved.

Important information for ARIXTRA® Starter Kit patients regarding Triad Group’s alcohol prep products

January 28, 2011

Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.

Pfizer Warns Consumers About Recalled Alcohol Swabs Included In RELISTOR Kits

January 27, 2011

Pfizer Progenics warns consumers about alcohol swabs included in some Relistor kits. Pfizer and Progenics are warning healthcare professionals and consumers about a recall involving Triad Group alcohol prep pads, which are included in kit presentation of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection in the United States.

The RELISTOR vial and other components of the kit are not affected by the defective Triad alcohol pad. RELISTOR sold in single vials also is unaffected by this recall.

Kanec USA, Inc. Recalls Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men Male Enhancement Herbal Supplement Capsules

January 25, 2011

Kanec USA Inc., has recalled All Lots of the company’s Nite Rider Maximum Sexual Enhancer For Men and STUD Capsule for Men because they were found adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction (ED), making the products unapproved new drugs. Representatives of the Food and Drug Administration (FDA) informed Kanec USA, Inc. of the laboratory analysis.

Important Information for Betaseron® (interferon beta 1-b) Consumers Regarding Triad Group’s Alcohol Prep Products

January 21, 2011

In the interest of patient safety, Bayer wants to ensure that U.S. patients and physicians using Bayer’s Betaseron are aware of the Triad recall.   The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria, Bacillus cereus, that could lead to life-threatening infections.
Triad alcohol prep pads packaged for use in the U.S. with Betaseron should not be used by patients.  There is NO involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging.   This issue is confined to the actual Triad alcohol prep products.  Triad alcohol prep products are not used in Betaseron packaging outside of the United States.   Bayer instructs patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash.  When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol.  Bayer is currently in the process of gathering additional information from both Triad and the U.S. Food and Drug Administration.  In the interim, Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad.  Bayer has posted this important information on its websites.    Further information on this Triad recall can be found on the FDA website at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm.  If you have additional questions, please consult with your pharmacist or healthcare provider or contact BETAPLUS at 1-800-788-1467 option 1 to speak to a BETA Nurse.  Or call Bayer at 1-888-84-BAYER, where operators will be available 24 hours a day to respond to questions from consumers or medical professionals.  Members of the media should call Rosemarie Yancosek at 973/305-5213 or Rose Talarico at 973/305-5302. Bayer will provide additional information when it becomes available. BETASERON® (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. IMPORTANT SAFETY INFORMATION

BETASERON should be used with caution in patients with depression. Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON. BETASERON should be used with caution in patients with seizure disorders or cardiac disease. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), injection-site reaction, asthenia (general weakness), flu-like symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. See “Warnings,” “Precautions,” and “Adverse Reactions” sections of full Prescribing Information available at www.betaseron.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.  For important risk and use information please see the full Prescribing Information available at www.betaseron.com.

Genentech Informs Customers Of Important Information About Triad Groups

January 15, 2011

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has become aware of the market recall of Triad Group’s alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines, Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase to customers in the U.S.
According to  (FDA) Medwatch communications, the recall was initiated due to concerns about potential contamination of the Triad Group’s products with the bacteria, Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
It is important to note, that Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a sterile gauze pad in conjunction with isopropyl alcohol for disinfecting the injection site prior to administration. Genentech is in discussion with the FDA and is currently assessing alternatives to address the situation. The company plans to issue a Dear Healthcare Provider letter to potential prescribers and pharmacists to make them aware of the Triad product recall and the need to discontinue use of the alcohol prep pads packaged with Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase.
Further information about the Triad Group recall can be found on the FDA website athttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm.
Patients should consult their healthcare provider for further information. Healthcare providers with questions may contact the Patient Resource Center at 1-877-436-3683 between the hours of 6 am and 5 pm Pacific Time.For the Boniva indication, full prescribing information, and important safety information, please visit http://www.boniva.com.
For the Fuzeon indication, full prescribing information, and important safety information, please visit http://www.fuzeon.com.
For the Nutropin A.Q. Pen indication, full prescribing information, and important safety information, please visit http://www.nutropin.com.For the Pegasys indication, full prescribing information, and important safety information including Boxed WARNING and Medication Guide, please visit http://www.pegasys.com.
For the TNKase indication, full prescribing information, and important safety information, please visit http://www.tnkase.com.

AngioScore Inc Recalls AngioSculpt® PTA Scoring Balloon Catheter, 0.018 OTW With Certain Balloon Sizes

January 10, 2011

AngioScore Incorporated, Fremont, CA initiated a worldwide recall of the AngioSculpt® PTA Scoring Balloon Catheter, 0.018” OTW, balloon sizes: 4.0x20mm, 5.0x20mm, and 6.0x20mm. This recall was initiated because of a small number of reports from the field of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element, wherein the proximal end of the scoring element remains secured to the catheter. Retained device fragments or significant arterial injury due to device failure may occur which may lead to death, need for percutaneous catheter-based interventions to remove retained device fragments, increased exposure to anesthesia, and loss of limb. There have been no reported injuries related to this failure mode to date.

Triad Group Recalls All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination

January 7, 2011

Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.

Teva Pharmaceuticals Recalls Metronidazole Tablets USP, 250mg Due to Low Weight Tablets

January 7, 2011

Teva Pharmaceuticals, U.S.A, is voluntarily recalling Metronidazole Tablets USP, 250mg, lot 312566, expiration date 05/2012. This product lot is being recalled due to the presence of underweight tablets.

Underweight tablets may not contain the full amount of active ingredient within a single tablet, a consumer may not receive the prescribed dose. This may cause the infection the drug was intended to treat to worsen or recur, which could be life-threatening when treating severe infections. To date, Teva Pharmaceuticals, U.S.A. has not received any adverse events associated with the use of this product lot.

Ritedose Corp. Recalls 0.083% Albuterol Sulfate Inhalation Solution

January 4, 2011

The Ritedose Corporation is recalling 0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25, 30, and 60 unit dose vials). This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults. This product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant health hazard. The following lot numbers manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60 are included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. No other Albuterol formulations or products are included in this recall.

PRock Marketing Recalls All Weight Loss Formulas Due To Sibutramine

January 3, 2011

PRock Marketing LLC has been informed by the Food and Drug Administration (FDA) that the weight loss dietary supplements sold and marketed contains an undeclared drug ingredient. The FDA lab analysist of the dietary supplements found the Authentic Formula Fruta Planta to contain 15.4 mg of Sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons. No illnesses or injuries have been reported to the company to date in connection with these products.

Cumberland Pharmaceuticals Recalls Acetadote Vials

January 2, 2011

Cumberland Pharmaceuticals Inc. announced today that it has implemented a recall of 6 lots of Acetadote® (acetylcysteine) Injection, the Company’s injectable treatment to prevent or lessen liver injury after ingestion of a potentially toxic quantity of acetaminophen. Cumberland informed the U.S. Food and Drug Administration (FDA) of its plans to voluntarily recall these lots of Acetadote as a precautionary measure based on observed particulate matter found in a very small number of vials. The source of the particulate matter was from the glass vial produced by a former supplier. The recall, which is not being undertaken on the basis of any known adverse medical events, affects a limited supply of product. “We are recalling certain lots manufactured by a previous packaging supplier as a precautionary measure, and believe the risk of any serious adverse medical events to be remote,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. “As part of ongoing quality assessment, we switched to a new vial packaging supplier in August of 2009. Patient safety, as always, remains our highest priority, and we are committed to taking the necessary steps to proactively protect patients from the potential of any safety risks.”

Drive Total Energy Issues A Voluntary Recall Of Rock Hard Extreme And Passion Coffee Dietary Supplements

January 1, 2011

Drive Total Energy recalls  Rock Hard Extreme and Passion Coffee Dietary Supplements. Drive Total Energy is conducting the voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label.

ev3 Recalls Specific Lots of NanoCross .014 inch OTW PTA Dilatation Catheter

December 29, 2010

ev3-catheterev3, a Covidien company, is recalling certain lots of the NanoCross™ .014″ OTW PTA Dilatation Catheter due to the potential for the catheter shaft to crack or break during use. Cracking or breaking of the catheter shaft may result in the inability to inflate or deflate the balloon, and may result in material separation and potential embolization. The device failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, tissue, injury, infarct, bleeding and/or death.

American Regent Recalls Certain Sodium Bicarbonate Injection Vials Due to Particulate Matter

December 29, 2010

American Regent is conducting a nationwide voluntary recall to the consumer and user level of ALL unexpired lots of the following products:

Sodium Bicarbonate Injection, USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial NDC # 0517-0639-25
and
Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL, Single Dose Vial NDC # 0517-1550-25

Abbott Diabetes Care Recalls Certain Lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips

December 24, 2010

Abbott Diabetes Care  has initiated a recall of 359 lots (approximately 359 million strips) of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico.
The affected test strips may give falsely low blood glucose results, which can lead users to try to raise their blood glucose when it is unnecessary and to fail to treat elevated blood glucose due to a falsely low reading.

The test strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium and OptiumEZ blood glucose monitoring systems. ReliOn Ultima test strips are used with the ReliOn Ultima blood glucose monitoring system. The blood glucose monitors are not being recalled and customers can continue to use the blood glucose monitors.

American Regent Recalls Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose Vial

December 24, 2010

American Regent is conducting a nationwide voluntary recall of the following:

Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 30 mL Multiple Dose Vial
NDC # 0517-4930-25

Lot #’s Exp. Dates
8811 12/2010
9093 02/2011
9195 03/2011
9296 04/2011

Pfizer Recalls One Lot Of Lipitor In The US – 19,000 Bottles Lipitor Recalled (40mg pills)

December 23, 2010

Pfizer has announced that it intends to recall one lot—approximately 19,000 bottles—of Lipitor 40 mg tablets (atorvastatin calcium) distributed in the U.S. The recall stems from one customer report of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged. The bottles were supplied by a third-party bottle manufacturer.

A medical assessment found that the risk of health consequences to patients appears to be minimal. The market action is the result of Pfizer’s increased surveillance of odor-related issues after other reports in the industry. This increased surveillance also led to three earlier recalls of Lipitor, implemented in August, October and November of 2010, in response to infrequent complaints of uncharacteristic odor. The odor is consistent with the presence of 2, 4, 6 tribromoanisole (TBA), which was found at a very low level in a complaint sample bottle during the investigation leading to the first product recall. Research indicates that a major source of TBA appears to be 2, 4, 6-tribromonophenol (TBP), a chemical used as a wood preservative. Although TBP often is applied to pallets used to transport and store a variety of products, Pfizer prohibits the utilization of TBP-treated wood in the shipment of its medicines.

RockHard Laboratories Recalls Specific Lots of the Dietary Supplements RockHard Weekend and Pandora

December 23, 2010

RockHard Laboratories announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names RockHard Weekend and Pandora specific to the following Lot Numbers:

RockHard Weekend Lot Numbers: 100159 and 100260 sold as blister packs, 3ct bottles and 8ct bottles. Pandora Lot Numbers: 100378 sold as blister packs.

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