Recalls
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Health Canada: Three Companies Recall Antipsychotic Drug Quetiapine
May 20, 2013 8:14 am | by The Canadian Press | News | CommentsHealth Canada says three companies are voluntarily recalling all lots of the antipsychotic drug quetiapine. A Health Canada news release says it's due to potential contamination with the antibiotic product clindamycin during the manufacturing process.
Compounding Pharmacy Recalls Sterile Drugs
April 22, 2013 9:01 am | News | CommentsA Florida-based compounding pharmacy is voluntarily recalling all lots of its sterile non-expired drug products sold nationwide over concerns the products are not sterile and may contain bacteria, Food and Drug Administration officials said Sunday.
Is Anyone Listening?
April 18, 2013 8:21 am | by Michael Auerbach, Editor in Chief | Blogs | CommentsLet’s face it – when you were growing up – perhaps mostly in your teen years – you never really listened to your parents. You might have pretended to, or developed that uncanny ability to not really listen – yet be able to recite the last sentence of whatever was said. A great skill indeed.
ApothéCure, Inc. Recalls All Lots of Sterile Products
April 16, 2013 9:11 am | News | CommentsApothéCure, Inc. is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes.
NuVision Pharmacy Recalls All Lots of Lyophilized Products
April 16, 2013 8:18 am | News | CommentsNuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.
Green Valley Drugs Recalls All Lots of All Sterile Products Due to Quality Control Concerns
April 12, 2013 8:48 am | News | CommentsGreen Valley Drugs is voluntarily recalling all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques.
Affirm XL Recalls Affirm XL Dietary Supplement Tablet, Lot 1190001 Due to Potential Health Risk
April 12, 2013 8:44 am | News | CommentsAffirm XL, Inc. is conducting a voluntary recall to the consumer level after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED).
Massachusetts Pharmacy Recalling Some Compounded Products
March 26, 2013 8:18 am | by BOB SALSBERG,Associated Press | News | CommentsA Massachusetts pharmacy issued a voluntary recall Monday of some of its sterile compounding products after "foreign matter" was found in drug vials during an unannounced inspection by state and federal officials. Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.
J&J Recalls All OneTouch Verio Blood Sugar Meters
March 25, 2013 11:28 am | by The Associated Press | News | CommentsJohnson & Johnson has announced a voluntary recall for all its OneTouch VerioIQ blood glucose meters in the U.S. because they do not provide a warning when a diabetic's blood sugar level is dangerously high. Instead, the meters turn off. The meters are made by J&J's LifeScan unit, which...
FDA: Georgia Pharmacy Recalling All Sterile Drugs
March 22, 2013 8:05 am | by MATTHEW PERRONE,AP Health Writer | News | CommentsThe Food and Drug Administration notified doctors Thursday that a Georgia compounding pharmacy responsible for a drug linked to eye infections has recalled all of its injectable medicines following a federal inspection. Augusta, Ga.-based Clinical Specialties Compounding Pharmacy issued a recall earlier this week on dozens of lots of the Roche drug Avastin after receiving reports of eye infections.
Affymax Plunges After Announcing Job Cuts
March 20, 2013 7:59 am | News | CommentsShares of Affymax Inc. lost more than half their value Tuesday after the company said it will eliminate 75 percent of its workforce and will consider options including a sale or bankruptcy after its only approved drug was recalled. After the market closed on Monday, Affymax said it will eliminate its commercial and medical affairs organizations, cutting a total of 230 jobs.
Clinical Specialties Issues Voluntary Nationwide Recall of Avastin Unit Dose Syringes due to Potential Serious Eye Infection
March 19, 2013 8:09 am | News | CommentsClinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.
Affymax Cuts Jobs, Mulls Options after Recall
March 19, 2013 8:04 am | News | CommentsAffymax Inc. shares tumbled in after-hours trading Monday after the biopharmaceutical company said it will cut 75 percent of its workforce following the recall of an anemia drug that caused severe allergic reactions and deaths among some users.
Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection
February 25, 2013 7:51 am | News | CommentsAffymax, Inc. and Takeda Pharmaceutical Company Limited (Takeda) have decided to voluntarily recall all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.
Reumofan Recalling All Lots of Reumofan Plus Tablets
February 20, 2013 8:08 am | News | CommentsReumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenac. Use of this product could result in serious and life-threatening injuries.
Gilead Issues a Voluntary Recall of One Lot of Vistide® (Cidofovir Injection) Due to Presence of Particulate Matter
February 19, 2013 8:10 am | News | CommentsGilead Sciences, Inc. has announced it is voluntarily recalling lot B120217A of Vistide ® (cidofovir injection) to the user level due to the presence of particulate matter found in some vials of this lot. Effects from intravenous injection of product with particulate matter can vary depending on the amount of particulate matter injected into the patient.
FDA Gives Zimmer Recall Its Most Serious Score
December 31, 2012 9:51 am | News | CommentsThe Food and Drug Administration said Friday that more than 300 spinal surgical instruments recalled last week by Zimmer Holdings Inc. could potentially cause serious injury or death.
Claudia’s Canine Cuisine® Voluntarily Recalls it’s Dogcandy® Brand of Holiday Hound Cake (7.5 Oz.) and Blueberry Hound Cake (7.5 Oz) Manufactured for, Distributed, and Sold ...
December 12, 2012 6:22 pm | by U.S. Food & Drug Administration | News | CommentsThe product in question is a single production run and packed in a 7.5 ounce paw print bag marked with a best by date of 08-2015. The best by date can be found on the ingredient label on the back of the package just above the UPC bar code.
Newman’s Own, Inc. Issues Voluntary Recall of Newman’s Own Lite Honey Mustard Dressing Due to Undeclared Milk
November 26, 2012 11:22 pm | by U.S. Food & Drug Administration | News | CommentsNewman's Own, Inc. announced the voluntary recall of Newman's Own Lite Honey Mustard Dressing because it contains undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the Newman's Own Lite...
Focus Products Group International, LLC Announces a Nationwide Recall of Cocoa Latte & trade; Hot Drink Makers Due to Possible Lead Risk
November 19, 2012 3:22 pm | by U.S. Food & Drug Administration | News | CommentsFocus Products Group International, LLC announces the following voluntary recall. Consumers should immediately stop using the Cocoa Latte™ Hot Drink Maker and contact the Focus Products Call Center for instructions on how to return the product and receive a replacement.
Germany Orders Recall of Some Novartis Flu Shots
October 26, 2012 4:19 am | by FRANK JORDANS,Associated Press | News | CommentsBERLIN (AP) — German authorities ordered a recall Thursday of some batches of Novartis flu vaccine as a precautionary measure after the company reported the appearance of small particles in the manufacturing process.
HeartSine Technologies, Ltd. Issues Global Correction Of Samaritan & reg; 300/300P PAD
October 25, 2012 9:23 am | by U.S. Food & Drug Administration | News | CommentsOn September 13, 2012, HeartSine Technologies, Ltd. initiated a voluntary global correction of certain Samaritan® 300/300P PAD public access defibrillators to address two separate issues that may affect the ability to deliver therapy to a patient in a sudden cardiac arrest (SCA)...
Ventlab Corporation Issues Nationwide Recall of its Manual Resuscitators
October 19, 2012 8:23 am | News | CommentsOn July 11, 2012, Ventlab Corporation initiated a nationwide recall of 14,602 of its manual resuscitators. The manual resuscitators as listed below have been found to potentially deliver little to no air/oxygen through the patient valve to the patient, which could result in life...
Kasel Associated Industries Recalls Boots & Barkley Roasted American Pig Ears and Boots & Barkley American Variety Pack Dog Treats Because of Possible Salmonella Health Risk
October 17, 2012 11:23 am | by U.S. Food & Drug Administration | News | CommentsKasel Associated Industries of Denver, CO is voluntarily recalling its BOOTS & BARKLEY ROASTED AMERICAN PIG EARS AND BOOTS & BARKLEY AMERICAN VARIETY PACK DOG TREATS product because it may be contaminated with Salmonella.
Kasel Associated Industries Recalls Boots & Barkley American Beef Bully sticks Because of Possible Salmonella Health Risk
September 21, 2012 5:22 pm | by U.S. Food & Drug Administration | News | CommentsKasel Associated Industries of Denver, CO is voluntarily recalling its BOOTS & BARKLEY 6 COUNT 5 INCH AMERICAN BEEF BULLY STICKS product because it may be contaminated with Salmonella.
