FDA Alerts Archive for 2015

January 2, 2015

• Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination

January 9, 2015

• Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy

January 10, 2015

• IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients

January 13, 2015

• Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected

January 21, 2015

• Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries

January 23, 2015

• 0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter

February 11, 2015

• Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials

February 24, 2015

• Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility

February 25, 2015

• Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall - Lack of Sterility Assurance

March 3, 2015

• Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
• Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning

March 6, 2015

• 0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter
• Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling

March 9, 2015

• Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction

March 10, 2015

• Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene

March 12, 2015

• Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination

March 19, 2015

• Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks

March 23, 2015

• Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug

March 24, 2015

• Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone

March 31, 2015

• Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed

April 2, 2015

• Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance

April 8, 2015

• IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients

April 10, 2015

• Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter

April 17, 2015

• Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication

April 22, 2015

• Mucinex Fast-MAX Products: Recall - Incorrect Labeling
• Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing

April 24, 2015

• Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials
• Injectable Products by Mylan: Recall - Presence of Particulate Matter

May 5, 2015

• Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter

May 15, 2015

• SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood

May 19, 2015

• Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions about Dose Confusion and Medication Errors

May 28, 2015

• Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury

June 16, 2015

• Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration

June 24, 2015

• Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes

July 1, 2015

• Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects
• Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality

July 9, 2015

• Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke

July 13, 2015

• Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration

July 16, 2015

• Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns

July 19, 2015

• 0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter

July 24, 2015

• Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance

July 27, 2015

• Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use
• Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter

July 30, 2015

• Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion

July 31, 2015

• Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination
• 0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port

August 4, 2015

• Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection

August 17, 2015

• Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use

August 18, 2015

• Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns

August 21, 2015

• Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes

August 24, 2015

• Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter

August 28, 2015

• OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure
• DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain

September 8, 2015

• Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning

September 10, 2015

• Medistat RX Sterile Drug Products: Recall - Possible Contamination
• Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density

September 11, 2015

• Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products

September 15, 2015

• Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program

September 17, 2015

• Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury

September 21, 2015

• Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger

September 22, 2015

• Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors

September 24, 2015

• Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance

October 2, 2015

• Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance

October 15, 2015

• Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength

October 21, 2015

• Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance

October 22, 2015

• Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies
• Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury

October 26, 2015

• Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks

October 29, 2015

• Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery

November 6, 2015

• Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death

November 17, 2015

• Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants

November 24, 2015

• Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3 (Cholecalciferol)

December 2, 2015

• OmniPod Insulin Management System by Insulet: Field Safety Notification - Reported Cases of Needle Mechanism Deployment Failure or Delay

December 4, 2015

• Lipo Escultura: Recall - Undeclared Drug Ingredients
• SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections

December 10, 2015

• Pink Bikini Dietary Supplement by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient
• Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination

December 16, 2015

• Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)

December 18, 2015

• Smart Lipo: Recall - Undeclared Drug Ingredients

December 23, 2015

• Various Products Distributed for Weight Loss by Bee Extremely Amazed: Recall - Undeclared Drug Ingredients
• La' Trim Plus, Jenesis and Oasis by BeeXtreme: Recall - Undeclared Drug Ingredients
• Apexxx by Nuway Distributors : Recall - Undeclared Drug Ingredient

December 31, 2015

• 4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag by Pharmedium: Recall - Discoloration