FDA Alerts Archive for 2018

January 2, 2018

• Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance

January 4, 2018

• Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial

January 11, 2018

• Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes
• Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

January 16, 2018

• Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions

January 18, 2018

• Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter

January 22, 2018

• Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling
• Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved

January 24, 2018

• "Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination
• Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination

February 1, 2018

• Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing

February 2, 2018

• Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination

February 13, 2018

• Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up

February 22, 2018

• Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease

February 23, 2018

• Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials

February 27, 2018

• Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine

March 2, 2018

• Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance

March 5, 2018

• Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials

March 6, 2018

• Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results

March 12, 2018

• Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella

March 16, 2018

• Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton

March 26, 2018

• Eclipse Kratom by Tamarack: Recall - Possible Salmonella Contamination

April 2, 2018

• Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination

April 3, 2018

• Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination
• Kratom-containing Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella

April 9, 2018

• Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution

April 10, 2018

• Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella

April 12, 2018

• Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance

April 13, 2018

• Coastal Meds to Recall All Products Marketed as Sterile

April 18, 2018

• Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil
• Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil

April 19, 2018

• Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination
• NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination

April 25, 2018

• Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

May 8, 2018

• Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter
• Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

May 10, 2018

• Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

May 18, 2018

• 7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil
• Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy
• Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects

May 21, 2018

• Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

May 23, 2018

• Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder
• 95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol

May 29, 2018

• X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination
• Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

May 31, 2018

• Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

June 4, 2018

• Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

June 15, 2018

• Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events After Receiving Eye Injections

June 22, 2018

• Kratom (mitragyna speciosa) powder products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

July 10, 2018

• Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

July 19, 2018

• Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

August 3, 2018

• Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

August 8, 2018

• Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination
• Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

August 9, 2018

• Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

August 21, 2018

• Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

August 24, 2018

• Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

August 27, 2018

• Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 mg Due to Labeling Mix-up
• Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle
• King Bio Issues Voluntary Nationwide Recall of All Aqueous-Based Products for Human and Animal Use Due to Possible Microbial Contamination

August 28, 2018

• Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

August 29, 2018

• Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination
• SGLT2 (sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

August 31, 2018

• FDA Announces Voluntary Recall of Montelukast Tablets by Camber Pharmaceuticals Due to Incorrect Drug in Bottles

September 5, 2018

• Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamination

September 6, 2018

• SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride Due to Presence of Precipitate

September 10, 2018

• Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

September 14, 2018

• FDA Alerts Consumers of BioLyte Laboratories Voluntary Recall of NeoRelief
• FDA alerts consumers not to use products distributed by Years to Your Health

September 27, 2018

• Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication

September 28, 2018

• Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

October 4, 2018

• FDA Alerts Consumers and Pet Owners of Silver Star Brand’s Voluntary Recall of Homeopathic Drug Products

October 11, 2018

• FDA Alerts Consumers of Sprayology’s Voluntary Nationwide Recall of Homeopathic Water-Based Medicines Due to Microbial Contamination

October 16, 2018

• Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

October 22, 2018

• Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

October 26, 2018

• Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

October 30, 2018

• Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

November 2, 2018

• FDA Alerts Patients and Health Care Professionals that Some EpiPen Auto-Injectors May Not Readily Slide Out of Carrier Tube
• Janssen Issues Voluntary Nationwide Recall for One Lot of Ortho-Novum 1/35 and Two Lots of Ortho-Novum 7/7/7 Due to Incorrect Veridate Dispenser Instructions

November 7, 2018

• Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

November 8, 2018

• Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

November 14, 2018

• Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

November 19, 2018

• FDA Alerts Health Care Professionals and Patients Not To Use Sterile Drug Products from Pharm D Solutions

November 20, 2018

• Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine
• Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex
• Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient

November 27, 2018

• Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry
• FDA Warns Consumers to Avoid Rhino Male Enhancement Products Found at Retailers Because of Undeclared and Potentially Dangerous Drug Ingredients

November 29, 2018

• FDA Warns About Rare But Serious Risks of Stroke and Blood Vessel Wall Tears with Multiple Sclerosis Drug Lemtrada (alemtuzumab)
• FDA Warns That Symptoms of a Serious Condition Affecting the Blood Cells Are Not Being Recognized with the Leukemia Medicine Idhifa (enasidenib)

December 4, 2018

• Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA Impurity in the Active Pharmaceutical Ingredient

December 5, 2018

• Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

December 7, 2018

• FDA Alerts Health Care Professionals and Patients Not to Use Drug Products Intended to be Sterile from Promise Pharmacy

December 11, 2018

• FDA Alerts Consumers Not to Use Two E-Liquids Sold by HelloCig Electronic Technology

December 17, 2018

• Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

December 20, 2018

• Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
• Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
• Terrific Care, LLC. / Medex Supply Dist, Inc. Issues Nationwide Recall of CoaguChek Test Strips

December 31, 2018

• Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity