FDA Alerts Archive for 2017

January 25, 2017

• Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial

January 27, 2017

• Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna

February 2, 2017

• Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions

February 9, 2017

• Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids
• Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter

February 15, 2017

• HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance

February 22, 2017

• XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient

February 25, 2017

• Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex

February 27, 2017

• Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance

March 8, 2017

• Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

March 9, 2017

• Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

March 14, 2017

• SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

March 15, 2017

• Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

March 21, 2017

• Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

March 30, 2017

• LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient

March 31, 2017

• EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

April 6, 2017

• Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance

April 19, 2017

• Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients

April 20, 2017

• Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women

April 21, 2017

• Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength

April 24, 2017

• 25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter

April 25, 2017

• Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure

April 27, 2017

• General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children

May 8, 2017

• GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic Steroids

May 16, 2017

• Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations

May 17, 2017

• LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results

May 22, 2017

• Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention
• Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients

May 25, 2017

• Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra

May 26, 2017

• Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients
• Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle

May 29, 2017

• Mibelas 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.: Recall - Out of Sequence Tablets and Missing Expiry/Lot Information

June 13, 2017

• Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets

June 14, 2017

• Topical Products by Phillips Company: Recall - Due to Concerns of Manufacturing Practices

June 15, 2017

• Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure
• Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston: Recall - Sub Potency
• Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance

June 17, 2017

• Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance

June 22, 2017

• Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance

June 23, 2017

• Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance

June 27, 2017

• Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance

July 6, 2017

• Ultra-Sten and D-Zine Capsules by Hardcore Formulations: Recall - Contains Anabolic Steroids
• Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall - May Crack or Break If Exposed To Certain Chemicals

July 12, 2017

• Sten Z and M1 Alpha Capsules by Andropharm: Recall - Contains Derivatives of Anabolic Steroids

July 24, 2017

• Super Panther 7K by Ultra Shop Supplement: Recall - Undeclared Drug Ingredients

July 25, 2017

• La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX: Recall - Undeclared Drug Ingredient
• Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

July 28, 2017

• Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging: Recall - Potential Mislabeling
• Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported

July 31, 2017

• 0.9 Percent Sodium Chloride Injection by ICU Medical: Recall - Presence of Particulate Matter
• Man of Steel 1 and Man of Steel 2: Recall - Undeclared Drug Ingredient

August 3, 2017

• Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination

August 4, 2017

• Compounded Curcumin Emulsion Product for Injection by ImprimisRx: FDA Investigation - Serious Adverse Events Associated with Use
• Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead

August 8, 2017

• Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use

August 10, 2017

• Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance
• Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories: Recall - Possible Product Contamination
• Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling

August 16, 2017

• Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers

August 18, 2017

• Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

August 23, 2017

• Ninjacof and Ninjacof A: Recall - Potential Burkholderia Cepacia Contamination

August 30, 2017

• Piyanping Anti-Itch Lotion: Recall - Incorrect Active Ingredient
• Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup: Recall - Potential Contamination with Burkholderia cepacia

August 31, 2017

• Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter
• Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold

September 1, 2017

• Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues
• Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium - Recall - Sub-Potency

September 5, 2017

• Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance

September 6, 2017

• Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing

September 7, 2017

• Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance

September 20, 2017

• Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
• Rhino 7, Papa Zen, Fifty Shades, and Grande X Dietary Supplements by Gadget Island: Recall - Undeclared Drug Ingredients

September 21, 2017

• Drug Safety Communication: Ocaliva (obeticholic acid) - Increased Risk of Serious Liver Injury
• Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient

October 3, 2017

• Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis

October 6, 2017

• Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures

October 7, 2017

• A1 Slim by Kiriko : Recall - Undeclared Drug Ingredients

October 21, 2017

• Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

October 23, 2017

• Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market Withdrawal

November 3, 2017

• Midazolam Injection, USP, 2 mg/2 mL by Fresenius Kabi: Recall - Reports of Blister Packages Containing Syringes of Ondansetron Injection

November 6, 2017

• Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility

November 8, 2017

• Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events

November 14, 2017

• Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication - FDA Warns Against Use

November 15, 2017

• Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death
• Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter

November 17, 2017

• Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets

November 21, 2017

• Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems

November 27, 2017

• Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination

November 28, 2017

• Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests

December 1, 2017

• Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients
• Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label

December 5, 2017

• Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

December 14, 2017

• Blue Pearl All Natural Male Enhancement Supplement: Recall - Undeclared Drug Ingredient

December 19, 2017

• Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings

December 20, 2017

• Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall - Presence of Glass Particles
• Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed

December 26, 2017

• Linezolid Injection by Auromedics Pharma: Voluntary Recall 600mg/300mL flexible bags- Due to Presence White Particle Matter That Has Been Identified as Mold