FDA Alerts Archive for 2022

January 12, 2022

• Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination
• Viona Issues Consumer Level Voluntary Nationwide Recall of Metformin HCl Extended- Release Tablets, USP 750 mg Due to Detection of NDMA Impurity
• FDA Warns About Dental Problems with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder and Pain

January 19, 2022

• Mylan Conducting Voluntary Recall of One Batch of Semglee (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens Due to the Potential for a Missing Label

January 27, 2022

• Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination

January 28, 2022

• AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate Matter

January 31, 2022

• Esupplementsales, LLC Issues a Nationwide Recall All Lots of Hard Dawn Due to the Presence of Undeclared Tadalafil

February 3, 2022

• Drug Safety Communication: Ukoniq (umbralisib) - FDA Investigating Possible Increased Risk of Death with Lymphoma

February 4, 2022

• Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil

February 8, 2022

• Your Favorite Shop Issues Voluntary Nationwide Recall of the Red Pill Capsules, Due to the Presence of Undeclared Tadalafil
• ABC SALES 1 INC Issues Voluntary Nationwide Recall of MAC DADDY RED and MAC DADDY PURPLE Capsules Due to the Presence of Undeclared Sildenafil and Tadalafil

February 9, 2022

• Celebrate Today Issues Voluntary Nationwide Recall of One Lot of Red Mammoth Due to the Presence of Undeclared Sildenafil and Tadalafil

February 10, 2022

• Positive-Health Issues Voluntary Nationwide Recall of RISE UP RED EDITION Capsules Due to the Presence of Undeclared Tadalafil

February 16, 2022

• TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene

February 18, 2022

• FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

March 3, 2022

• B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 250ML in Excel Due to Fluid Leakage or Low Fill Volume

March 4, 2022

• Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions

March 7, 2022

• Tennessee Technical Coatings Corp. Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol
• Fresenius Kabi Issues Voluntary Recall of Sodium Acetate Injection, USP Due to the Presence of Particulate Matter

March 10, 2022

• Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification

March 21, 2022

• Pfizer Voluntary Nationwide Recall of Lots of Accuretic, Quinapril and Hydrochlorothiazide, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-NitrosoQuinapril Content
• Letter to Health Care Personnel - Prefilled Saline Flush Syringe Conservation Strategies

March 22, 2022

• Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity
• Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of Symjepi (Epinephrine) Injection for Potential Manufacturing Defect

March 24, 2022

• Plastikon Healthcare Issues Voluntary Nationwide Recall of Certain Products Due to Microbial Contamination

March 29, 2022

• Teva Issues Voluntary Nationwide Recall of One Lot of Idarubicin Hydrochloride Injection USP 5 mg/5 mL Due to the Presence of Particulate Matter

March 30, 2022

• Drug Safety Communication - FDA Recommends Thyroid Monitoring in Babies and Young Children Who Receive Injections of Iodine-Containing Contrast Media for Medical Imaging
• FDA Warns Patients and Health Care Professionals Not to Use Sterile Products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding

April 12, 2022

• Mylan Issues Voluntary Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label

April 19, 2022

• FDA Works to Protect Consumers from Potentially Harmful OTC Skin Lightening Products

April 20, 2022

• FDA Warns Consumers Not to Purchase or Use Artri and Ortiga Products, Which May Contain Hidden Drug Ingredients

April 22, 2022

• Pfizer Voluntary Nationwide Recall of Lots of Accupril (Quinapril HCl) Due to N-Nitroso-Quinapril Content

April 26, 2022

• FDA Alerts Customers to Voluntary Recall of Compounded Drugs Due to Sterility Issues by Drug Depot, LLC, dba APS Pharmacy

April 29, 2022

• Bosentan REMS Requirements will Change June 27, 2022

May 2, 2022

• Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination

May 4, 2022

• FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

May 23, 2022

• Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

May 28, 2022

• Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients

June 1, 2022

• FDA Approval of Lymphoma Medicine Ukoniq (umbralisib) is Withdrawn Due to Safety Concerns

June 8, 2022

• Plastikon Issues Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension Due to Microbial Contamination

June 9, 2022

• Green Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination

June 14, 2022

• Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone

June 21, 2022

• Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

June 29, 2022

• Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up

June 30, 2022

• Drug Safety Communication: Copiktra (duvelisib) - FDA Warns about Possible Increased Risk of Death and Serious Side Effects

July 6, 2022

• Mylan Pharmaceuticals Inc. Issues Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens U-100, Due to the Potential of Missing Labels on Some Pens

July 13, 2022

• Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), Due To The Potential Presence of Visible Particulate

July 15, 2022

• Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

July 19, 2022

• MKS Enterprise LLC Voluntary Recalls of Dose Vital VIP Vital Honey Due to Presence of Undeclared Tadalafil

July 21, 2022

• Voluntary Recall of Certain Family Dollar Over-the-Counter Products

July 25, 2022

• Ultra Supplement LLC Issues Voluntary Nationwide Recall of Sustango Due to the Presence of Undeclared Tadalafil

July 26, 2022

• Vi-Jon, LLC Expands Voluntary Nationwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination
• Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada

July 29, 2022

• Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene

August 2, 2022

• Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil

August 3, 2022

• Plastikon Expands Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension Due to Microbial Contamination

August 4, 2022

• Vi-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

August 9, 2022

• FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

August 18, 2022

• FDA Alerts Patients, Caregivers, and Health Care Providers of Cross-Compatibility Issues with Autoinjector Devices That Are Optional for Use with Glatiramer Acetate Injection
• FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

August 22, 2022

• Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates

September 19, 2022

• Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer (Alcohol) Gel 65% Due to the Presence of Benzene

September 26, 2022

• Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of Particulate Matter

September 28, 2022

• Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil

September 29, 2022

• Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up

October 13, 2022

• Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage

October 24, 2022

• Aurobindo Pharma USA, Inc. Initiates Recall of Two Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity

October 25, 2022

• Mylan Institutional LLC, a Viatris Company, Issues a Voluntary Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, Due to Glass Particulates in a Syringe

November 8, 2022

• FDA Alerts Health Care Professionals of Risks to Patients Exposed to Xylazine in Illicit Drugs

November 17, 2022

• FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease

November 22, 2022

• FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis Receiving Osteoporosis Medicine Prolia (denosumab)

November 29, 2022

• Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage

December 21, 2022

• Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-Nitroso-Quinapril Impurity

December 27, 2022

• Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot Due to Product Mix-Up
• Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates
• GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination