FDA Alerts Archive for 2011
January 1, 2011
January 3, 2011
- Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials
- Fruta Planta: Public Notification - Undeclared Drug Ingredient
- Rock Hard Extreme and Passion Coffee by Drive Total Energy: Recall - Undeclared Drug Ingredient
January 6, 2011
January 10, 2011
January 13, 2011
- Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication
- Celerite Slimming Capsules: Undeclared Drug Ingredient
January 14, 2011
January 26, 2011
February 4, 2011
February 5, 2011
February 7, 2011
- Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling
- Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination
February 16, 2011
February 17, 2011
- Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage
- Terbutaline: Label Change - Warnings Against Use for Treatment of Preterm Labor
February 21, 2011
February 22, 2011
February 23, 2011
February 25, 2011
March 1, 2011
March 2, 2011
- Unapproved Cough, Cold, Allergy Products: FDA Prompts Removal From Market
- Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use
March 4, 2011
March 8, 2011
March 9, 2011
March 16, 2011
March 18, 2011
- H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination
- American Regent Injectable Products: Recall - Visible Particulates in Products
- H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination
March 23, 2011
March 24, 2011
March 28, 2011
- Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant
- Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling
- Celerite Slimming Tea: Recall - Undeclared Drug Ingredient
March 29, 2011
- X-Hero and Male Enhancer: Recall - Undeclared Drug Ingredient
- Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A and D
March 30, 2011
- Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals
- Pradaxa (dabigatran etexilate mesylate) Capsules: Special Storage and Handling Requirements
April 5, 2011
April 6, 2011
April 7, 2011
April 8, 2011
April 14, 2011
- Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults
- Benicar (olmesartan): Ongoing Safety Review
April 15, 2011
- Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
- Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes
- Topamax (topiramate): Recall - Musty Odor
April 22, 2011
April 27, 2011
May 2, 2011
May 3, 2011
May 6, 2011
- Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems
- American Regent Injectable Products: Recall - Visible Particulates in Products
May 10, 2011
May 11, 2011
May 16, 2011
May 18, 2011
May 20, 2011
May 23, 2011
May 26, 2011
May 31, 2011
June 2, 2011
June 3, 2011
June 5, 2011
June 7, 2011
- Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men: Recall - Undeclared Drug Ingredient
- American Regent Injectable Products: Recall - Visible Particulates in Products
June 8, 2011
- Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations
- Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination
June 9, 2011
June 13, 2011
- Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion
- Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis
June 15, 2011
- Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer
- Indomethacin for Injection: Recall - Particulate Matter in One Lot
- Indomethacin for Injection: Recall of One Lot - Particulate Matter
June 16, 2011
- Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events
- American Regent Injectable Products: Recall - Visible Particulates in Products
June 20, 2011
June 24, 2011
June 27, 2011
- Nature Relief Instant Wart and Mole Remover: Recall - Risk of Severe Skin Burns
- Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets
- Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled
June 29, 2011
June 30, 2011
July 7, 2011
July 11, 2011
July 15, 2011
July 20, 2011
July 21, 2011
- Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer
- Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events
July 22, 2011
July 26, 2011
- Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications
- Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications
- CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure
July 27, 2011
August 3, 2011
August 4, 2011
- Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death
- Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency
August 24, 2011
August 26, 2011
September 1, 2011
- Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment
- Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions
September 7, 2011
September 15, 2011
September 16, 2011
- Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error
- H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination
September 27, 2011
October 3, 2011
October 6, 2011
October 11, 2011
October 21, 2011
- Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications
- Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications
- Nostrilla Nasal Decongestant: Recall - Bacterial Contamination
October 24, 2011
October 25, 2011
October 27, 2011
November 4, 2011
- Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events
- Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults
November 9, 2011
November 14, 2011
December 7, 2011
December 14, 2011
December 15, 2011
December 19, 2011
December 20, 2011
December 22, 2011
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