FDA Alerts Archive for 2013

January 10, 2013

• Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses
• Mobius brand Mitosol (mitomycin for solution) Kit for Ophthalmic Use: Recall-May Not be Sterile

January 18, 2013

• Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall - Bottle May Contain Meclizine HCl 25 mg Tablets

January 25, 2013

• Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury

January 28, 2013

• Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility

February 16, 2013

• Vistide (Cidofovir Injection) by Gilead: Recall - Presence Of Particulate Matter

February 19, 2013

• Reumofan Plus: Recall - Undeclared Drug Ingredient

February 20, 2013

• Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication - Risk of Rare, But Life-Threatening Adverse Events or Death

February 23, 2013

• Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions

February 25, 2013

• Maxiloss Weight Advanced Softgels: Recall - Undeclared Drug Ingredient

February 26, 2013

• Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death

March 12, 2013

• Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms
• Night Bullet: Recall - Undeclared Drug Ingredient

March 14, 2013

• Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas

March 18, 2013

• Med Prep Consulting Inc. Compounded Products: Recall - Potential Mold Contamination

March 20, 2013

• Avastin Unit Dose Syringes by Clinical Specialties: Recall - Potential For Serious Eye Infection

March 21, 2013

• Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance

March 27, 2013

• Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed

April 1, 2013

• Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates

April 5, 2013

• Bivigam Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed

April 9, 2013

• ROCK-It MAN Male Enhancement Capsules: Recall - Undeclared Drug Ingredient

April 11, 2013

• Affirm XL Recall - Undeclared Drug Ingredient
• Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns

April 16, 2013

• Sterile Products Compounded, Repackaged, and Distributed by ApothéCure: Recall - Sterility Assurance Concerns
• Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns

April 22, 2013

• Balanced Solutions All Sterile Compounded Products: Recall - Lack of Sterility Assurance

April 23, 2013

• LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall: Failure to Provide a Warning at Extremely High Blood Glucose Levels
• All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance

April 26, 2013

• Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall - Particulate Matter
• Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration
• Eba Multivitamin Supplement By Saratoga Therapeutics LLC: Recall - Allergy Alert On Undeclared Milk Components

April 30, 2013

• Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death
• Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution
• Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall - Labeling Issue Identified

May 2, 2013

• American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient

May 6, 2013

• Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches
• Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion

May 7, 2013

• Bullet Proof: Public Notification - Undeclared Drug Ingredient
• Lightning Rod Capsules: Recall - Undeclared Drug Ingredient

May 8, 2013

• The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
• SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient

May 9, 2013

• Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy

May 14, 2013

• Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

May 17, 2013

• Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance

May 18, 2013

• All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance

May 20, 2013

• Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result

May 21, 2013

• Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials

May 24, 2013

• Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections

May 28, 2013

• Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections

May 29, 2013

• Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials

May 30, 2013

• Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
• Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor

June 7, 2013

• Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections

June 10, 2013

• Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected

June 11, 2013

• Bethel Nutritional Consulting, Inc. Bethel 30: Recall: Undeclared Drug Ingredient.

June 12, 2013

• Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets

June 13, 2013

• Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections

June 18, 2013

• Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection

June 19, 2013

• Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tablets

June 24, 2013

• Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding
• Oxyphen, Phentalene, Phen FX, and Red Vipers by Beta Labs, LTD: Recall - Contains DMAA

June 28, 2013

• JaDera and Xiyouji Qingzhi Dietary Supplements by Dolphin Intertrade Corp.: Recall - Undeclared Drug Ingredient

July 2, 2013

• Benztropine Mesylate Injection by Fresenius Kabi USA: Recall - Potential Presence Of Glass Particles

July 3, 2013

• Olmesartan Medoxomil: Drug Safety Communication - Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy)
• Recombivax HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp and Dohme Corp.: Recall - Potential For Cracked Vials

July 5, 2013

• Estarylla (norgestimate and ethinyl estradiol): Recall - Report of Placebo Tablet Present in Row of Active Tablets

July 15, 2013

• Silver Sword and Clalis by hardmenstore.com: Recall - Undeclared Drug Ingredient

July 22, 2013

• Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall - Mislabeled Packaging
• Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules: Recall - Undeclared Drug Ingredients

July 23, 2013

• Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients
• MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor
• Esbelin Silouttte Te and Esbelin Siloutte Vitamin Supplement: Recall - Undeclared Drug Ingredients

July 26, 2013

• Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems
• Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning - Undeclared Ingredients

July 29, 2013

• Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result
• Mefloquine Hydrochloride: Drug Safety Communication - Label Changes Due To Risk of Serious Psychiatric and Nerve Side Effects
• GE Healthcare Nuclear Medicine Systems: Class I Recall - Serious Injuries or Deaths Could Occur

August 1, 2013

• Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance
• Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions

August 2, 2013

• Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter

August 6, 2013

• BEST SLIM 40 Pills By CTV Best Group: Recall - Undeclared Ingredients
• Bethel Advance And Quick Thin Products By Bethel Nutritional Consulting, Inc.: Recall - Undeclared Ingredients

August 7, 2013

• Tranquility by Health and Beyond, LLC: Recall - Undeclared Drug Ingredient

August 9, 2013

• Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

August 10, 2013

• Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

August 15, 2013

• Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage

August 17, 2013

• Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling

August 20, 2013

• Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper
• Esbelder Man Capsules, Esbelder Fem Capsules, And Esbelder Siloutte Capsules Vitamin Supplements By Herbal Give Care LLC: Recall - Undeclared Ingredients

August 21, 2013

• Jack Rabbit Dietary Supplement: Recall - Undeclared Drug Ingredients

August 22, 2013

• Ortiga: Public Notification - Contains Hidden Drug Ingredient

August 27, 2013

• Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient
• Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination
• JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor
• Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance

August 29, 2013

• Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in Four Lots
• Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection

September 3, 2013

• Aminosyn II 10 percent, Sulfite-Free (Hospira): Recall - Particulate Matter Noted in One Lot

September 5, 2013

• Medaus Pharmacy Sterile Compounded Products - Recall: Inability to Confirm Sterility

September 8, 2013

• Altaire Pharmaceuticals Carboxymethylcellulose Sodium 0.5 Percent Ophthalmic Solution Sold Under Wal-Mart, CVS, and Target Brands: Recall - Preservative May Not Be Effective Through Expiry
• University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance
• MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz: Recall - Particles Identified

September 9, 2013

• Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor

September 10, 2013

• Park Compounding Sterile Medication: Recall – Concerns of Sterility Assurance

September 12, 2013

• Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance

September 13, 2013

• Creafuse Powder Grape and Creafuse Powder Fruit Punch: Recall - Contains DMAA
• Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter

September 17, 2013

• Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang: Public Notification - Undeclared Drug Ingredient
• HeartSine Technologies Samaritan 300/300P PAD Public Access Defibrillators: Recall - Power, Battery Issues

September 20, 2013

• Baxter Dual Luer Lock Caps: Recall - Presence of Loose Particulate Matter Found In Packaging

September 23, 2013

• Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure

September 24, 2013

• Xzen 1200, Xzen Gold and Xzen XPress: Public Notification - Undeclared Ingredients
• XZone Premium: Public Notification - Undeclared Drug Ingredient
• Wood-E: Public Notification - Undeclared Drug Ingredient

September 25, 2013

• W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen Lotion: Recall - Microbial Contamination
• Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation

September 27, 2013

• Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death
• The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

October 1, 2013

• Virilis Pro, PHUK and Prolifta Capsules : Recall - Undeclared Ingredients

October 2, 2013

• Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier

October 4, 2013

• 1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate

October 8, 2013

• OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use
• Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter

October 9, 2013

• Slim Fortune, Lidiy And Slim Expert Dietary Supplement: Recall - Undeclared Ingredients

October 10, 2013

• Perfect Body Solutions and Burn 7: Public Notification - Undeclared Ingredients
• Dr. Mao Slimming Capsules: Public Notification - Undeclared Ingredients
• Bella Vi Insane Amp’d And Bella Vi Amp’d Up: Public Notification - Undeclared Ingredients
• Be Inspired: Public Notification - Undeclared Ingredients

October 11, 2013

• Iclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins

October 15, 2013

• Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter

October 17, 2013

• Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results

October 21, 2013

• Hospira brand Lidocaine and Marcaine: Recall - Presence Of Particulate
• Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials

October 31, 2013

• Iclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins

November 1, 2013

• Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration

November 2, 2013

• Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with Co-packaged Oral Syringe

November 6, 2013

• Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis

November 7, 2013

• Iclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins

November 10, 2013

• OxyElite Pro Dietary Supplements by USP Labs: Recall - Products Linked to Liver Illnesses

November 12, 2013

• Vega One Nutritional Shakes and Vega Sport Performance Protein: Recall - Traces of Antibiotic

November 13, 2013

• Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection

November 15, 2013

• VitaliKOR Fast Acting: Recall - Undeclared Drug Ingredients

November 16, 2013

• Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance

November 19, 2013

• RezzRX: Recall - Undeclared Drug Ingredients
• Rhino 5 Plus, Maxtremezen and Extenzone: Recall - Undeclared Drug Ingredients

November 20, 2013

• Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death
• P-Boost, NatuRECT by Tendex: Recall - Undeclared Drug Ingredient

November 21, 2013

• Adipotrim XT by Deseo Rebajar: Recall - Undeclared Drug Ingredient

November 22, 2013

• Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates

November 25, 2013

• Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions

November 27, 2013

• Nitroglycerin in 5% Dextrose Injection by Baxter: Recall - Particulate Matter

November 28, 2013

• FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall - Erroneously Low Blood Glucose Results

December 1, 2013

• Hydravax Dietary Supplement by IQ Formulations: Recall - Possible Undeclared Drug Ingredient

December 3, 2013

• Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions
• HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock

December 12, 2013

• Nipple Aspirate Test: Safety Communication - Breast Cancer Screening Test Is Not An Alternative To Mammography

December 16, 2013

• Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles

December 17, 2013

• Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections

December 19, 2013

• Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance

December 20, 2013

• Iclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins

December 23, 2013

• Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning - Undeclared Ingredients

December 24, 2013

• Burn 7 Capsules by Deseo Rebajar: Recall - Undeclared Drug Ingredient
• Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter

December 27, 2013

• Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution