FDA Alerts Archive for 2016

January 4, 2016

• Noxafil (posaconazole): Drug Safety Communication - Dosing Errors when Switching between Different Oral Formulations; Label Changes Approved

January 5, 2016

• Baxter IV Solutions: Recall - Potential Presence of Particulate Matter

January 6, 2016

• Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container

January 8, 2016

• L.G Compounded Asafoetida Powder by Shakti Group: Recall - Potential Contamination with Salmonella

January 9, 2016

• Multiple Products by R Thomas Marketing: Recall - Undeclared Drug Ingredient

January 13, 2016

• Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup

January 16, 2016

• Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert - Contains Unidentified Morphine
• Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance

January 27, 2016

• Baxter IV Solutions (Select Lots): Recall - Potential for Leaking Containers and Particulate Matter

January 28, 2016

• SPOTCHEM II Test Strips by Arkray: Class I Recall - Inaccurate Blood Sugar Readings
• Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning
• Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning

January 29, 2016

• Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient

February 17, 2016

• Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by by Pharmakon Pharmaceuticals: Recall - Super-potent Product

February 18, 2016

• 0.9 Percent Sodium Chloride Solution for Irrigation by Baxter: Recall - Presence of Particulate Matter

March 5, 2016

• Fluconazole Injection, USP, (in 0.9 Percent Sodium Chloride) 200mg per 100mL: Recall - Elevated Impurity

March 9, 2016

• Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert - Lack of Sterility Assurance

March 10, 2016

• Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

March 15, 2016

• Eye Drops: FDA Statement - Potential Risk of Loose Safety Seals

March 21, 2016

• Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter

March 22, 2016

• Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications
• NOW Health Group Dietary Supplements: Recall - Mislabeling

March 23, 2016

• Best Bentonite Clay by Best Bentonite: FDA Alert - Risk of Lead Poisoning

March 28, 2016

• Compounded Products by Reliable Drug Pharmacy: Recall - Potential for Mislabeling and Lack of Quality Assurance

March 29, 2016

• 5 Percent Dextrose Injection USP in PAB Container by B. Braun Medical: Recall - Leakage and/or Particulate Matter

April 1, 2016

• Sterile Drug Products by Medaus Pharmacy: FDA Alert - Lack of Sterility Assurance

April 5, 2016

• Continuum Labs LGD-4033 by Invisiblu International: Recall - Investigational Drug Not Approved for Use
• Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure

April 8, 2016

• Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function

April 12, 2016

• Super Herbs Capsules: Recall - Undeclared Drug Ingredients

April 14, 2016

• 50 Percent Magnesium Sulfate Injection, USP by Hospira: Recall - Presence Of Particulate Matter

April 16, 2016

• Sterile Drug Products from Pharmakon Pharmaceuticals, Inc: CDER Statement - FDA alerts health care professionals not to use due to a lack of sterility assurance and other quality issues

April 26, 2016

• Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter
• Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy

May 2, 2016

• Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall - Undeclared Drug Ingredients
• Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)

May 3, 2016

• Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems

May 9, 2016

• PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter

May 10, 2016

• Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions

May 12, 2016

• Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections

May 13, 2016

• BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries
• SOS Telecom Products: Recall - Undeclared Drug Ingredient

May 18, 2016

• Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
• Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance

May 19, 2016

• Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death

June 2, 2016

• Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars

June 6, 2016

• Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk

June 7, 2016

• Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse
• Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients

June 8, 2016

• Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk

June 14, 2016

• Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings

July 16, 2016

• Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. cepacia

July 22, 2016

• HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance

July 26, 2016

• Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects

August 3, 2016

• Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

August 5, 2016

• 0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter

August 9, 2016

• Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination

August 12, 2016

• DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

August 18, 2016

• Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution: Recall - Inadequate Seal of Blister Pack

August 19, 2016

• Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter

August 22, 2016

• Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination

August 29, 2016

• Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards
• Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

August 31, 2016

• Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring New Boxed Warnings About Serious Risks and Death

September 7, 2016

• Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use
• Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination

September 8, 2016

• Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

September 9, 2016

• GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe

September 15, 2016

• Hyoscyamine sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results

September 22, 2016

• Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance

September 30, 2016

• Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children

October 4, 2016

• Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

October 25, 2016

• Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

November 8, 2016

• Skinny Bee Diet by Love My Tru Body: Recall - Undeclared Drug Ingredients

November 15, 2016

• Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes

November 18, 2016

• GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk

November 21, 2016

• Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance
• Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

November 25, 2016

• Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids

November 26, 2016

• DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk

December 1, 2016

• Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient
• Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients

December 12, 2016

• Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer

December 14, 2016

• General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women

December 16, 2016

• Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised