Qualitest Pharmaceuticals Recalls Hydrocodone Bitartrate, Acetaminophen and Phenobarbital Tablets
February 7, 2011
Qualitest Pharmaceuticals is recalling certain lots of Hydrocodone Bitartrate and Acetaminophen Tablets, as well as Phenobarbital Tablets. A bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled as Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and could also be affected.
Watson Announces Important Action Related to Nationwide Recall of Triad Alcohol Prep Products Included in Products
February 5, 2011
American Regent Recalls Potassium Phosphates Injection, USP 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial, Lot# 0048 Due to Translucent Visible Particles
February 5, 2011
American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:
Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium
5 mL Single Dose Vial
NDC # 0517-2305-25
Lot #0048
Exp Date: January, 2012
Shaping Beauty Recalls Weight Loss Pills Found to Contain an Undeclared Drug Ingredient
February 4, 2011
CELERITE™ SLIMMING CAPSULES
American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056 Due to Translucent Visible Particles
February 4, 2011
Sodium Thiosulfate Injection, USP, 10% (100 mg/mL), 10 mL Single Dose Vial
NDC # 0517-1019-05
Lot #0056
Exp Date: January, 2012
PLEASE NOTE: This recall, initiated on February 2, 2011 to the User or Consumer Level, is for lot # 0056 Only. No other lots or sizes of Sodium Thiosulfate Injection, USP are subject to this voluntary recall.
Godi International, Corp. Recalls All Variations of Reduce Weight Fruta Planta / Reduce Weight Dietary Supplement.
February 3, 2011
Godi International, Corp., located in South Florida is announcing a recall of Fruta Planta weight loss dietary supplements because the products contain Sibutramine an undeclared drug ingredient. The FDA lab analysis of the dietary supplements found the Authentic Formula Fruta Planta to contain 18 mg of Sibutramine. No illnesses or injuries have been reported to Godi International, Corp in connection with these products. Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. All lots of the Fruta Planta and Reduce Weight Fruta Planta Dietary Supplement Products are being recalled. The following recalled products contain the active pharmaceutical ingredient Sibutramine:
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
McNeil Recalls Certain Tylenol, Benadryl, Sudafed PE, & Sinutab Products
January 14, 2011
McNeil Consumer Healthcare is recalling certain lots of TYLENOL® Arthritis Pain, TYLENOL® 8 Hour, and TYLENOL® upper respiratory products, as well as certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® over-the-counter (OTC) medications distributed at the wholesale level in the United States, the Caribbean, and Brazil.
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.”
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