Important Information for Extavia (interferon beta 1-b) Patients Regarding Triad Group’s Alcohol Prep Products
February 1, 2011
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
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 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
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
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
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, 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
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
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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