FDA Alerts Archive for 2021

January 4, 2021

• Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
• Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol

January 8, 2021

• Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter

January 15, 2021

• FDA Updates Vinca Alkaloid Labeling for Preparation in Intravenous Infusion Bags Only

January 25, 2021

• Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

January 26, 2021

• FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers

January 27, 2021

• Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling

February 3, 2021

• Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel Measurement Markings

February 4, 2021

• Initial Safety Trial Results Find Increased Risk of Serious Heart-Related Problems and Cancer with Xeljanz, Xeljanz XR (tofacitinib)

February 16, 2021

• Adamssecret.co Issues Voluntary Nationwide Recall of Adam’s Secret Extra Strength 1500 and 3000 Capsules Due to Presence of Undeclared Sildenafil and/or Tadalafil

March 9, 2021

• Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength

March 11, 2021

• Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance

March 17, 2021

• PNHC, LLC d/b/a Heal the World Issues Voluntary Nationwide Recall of Heal the World Hand Sanitizer Packaged in 9.6 Ounce Bottles Because They Resemble Small Water Bottles

March 24, 2021

• Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label Mix-Up
• FDA Requires a Warning about Guillain-Barré Syndrome (GBS) be Included in the Prescribing Information for Shingrix

March 25, 2021

• FDA Warns That Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm
• Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization

March 26, 2021

• Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and Tadalafil

March 31, 2021

• Drug Safety Communication: Lamictal (lamotrigine) - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease
• Apotex Corp. Issues Voluntary Nationwide Recall of Guanfacine Extended-Release Tablets 2mg Due to Trace Amounts of Quetiapine Fumarate

April 2, 2021

• A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling

April 14, 2021

• Janssen COVID-19 Vaccine Frequently Asked Questions (Updated April 14, 2021)

April 16, 2021

• Durisan Announces a Voluntary Recall Expansion of its Antimicrobial Hand Sanitizer

April 30, 2021

• Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency

May 4, 2021

• Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate
• Hospira Recalls 0.5% Bupivacaine Injection and 1% Lidocaine Injection, Due to Mislabeling

May 10, 2021

• Novo Nordisk Issues Voluntary Nationwide Recall of Levemir, Tresiba, Fiasp, Novolog and Xultophy Product Samples Due to Improper Storage Temperature Conditions

May 11, 2021

• Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil

May 12, 2021

• Hi Tech Pharmaceuticals Issues Voluntary Recall on Lipodrene w/25mg Ephedra Extract Dietary Supplement Due to the Presence of 1,4-dimethylamylamine (DMAA)

May 17, 2021

• Recall Expansion of Durisan Non-Alcohol Hand Sanitizer

May 19, 2021

• Miracle8989 Issues Voluntary Nationwide Recall of PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000, Due to Presence of Undeclared Sildenafil and Tadalafil

May 21, 2021

• FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom

May 26, 2021

• FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility
• FDA Restricts Use of Ocaliva (obeticholic acid) in Primary Biliary Cholangitis Patients with Advanced Cirrhosis Due to Risk of Serious Liver Injury

June 11, 2021

• Viona Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg Due to the Detection of NDMA Impurity

June 16, 2021

• FDA Warns That Vapors From Alcohol-Based Hand Sanitizers Can Have Side Effects

July 1, 2021

• Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter

July 2, 2021

• FDA Alerts Health Care Professionals and Patients to a Voluntary Recall of Chantix (varenicline) to the Warehouse Level

July 7, 2021

• FDA Safety Communication: Labeling Changes on Mortality, Kidney Injury, and Excess Bleeding with Hydroxyethyl Starch Products

July 9, 2021

• Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older

July 14, 2021

• Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific Neutrogena® and Aveeno® Aerosol Sunscreen Products Due to the Presence of Benzene

July 19, 2021

• Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of Chantix (Varenicline) Tablets Due to N-Nitroso Varenicline Content
• Alpha Male Plus Issues Voluntary Nationwide Recall of Alpha Male Plus Male Enhancer Due to the Presence of Undeclared Tadalafil

July 20, 2021

• FDA Requests Removal of Strongest Warning Against Using Cholesterol-Lowering Statins During Pregnancy; Still Advises Most Pregnant Patients Should Stop Taking Statins

July 22, 2021

• HIS Issues Voluntary Nationwide Recall of Miss Slim Due to the Presence of Undeclared Sibutramine

July 28, 2021

• FDA Alerts Patients and Health Care Professionals About Clinical Trial Results Showing an Increased Risk of Death Associated with Pepaxto (melphalan flufenamide)

August 6, 2021

• KVK Tech Inc., Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5mL Due to Temperature Abuse

August 10, 2021

• SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination

August 11, 2021

• Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine

August 16, 2021

• Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of Chantix (varenicline) Tablets Due to N- Nitroso Varenicline Content

August 30, 2021

• Teligent Pharma, Inc. Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency

September 1, 2021

• FDA Requires Warnings About Increased Risk of Serious Heart-Related Events, Cancer, Blood Clots, and Death for JAK Inhibitors That Treat Certain Chronic Inflammatory Conditions

September 7, 2021

• ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the Presence of Particulate Matter

September 8, 2021

• Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq (Vancomycin HCl for Oral Solution) 50 mg/mL Kit Due to a Mix-Up of the Diluent

September 13, 2021

• Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination

September 16, 2021

• Pfizer Expands Voluntary Nationwide Recall to include All Lots of Chantix® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

September 17, 2021

• FDA Alerts Patients and Health Care Professionals Not to Use Compounded Products Intended to be Sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy

September 21, 2021

• IntegraDose Compounding Services, LLC Issues Voluntary Nationwide Recall of Cefazolin Injection Products Due to a Lack of Sterility Assurance

September 24, 2021

• Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of Glucagon® Emergency Kit Due to Loss of Potency

September 29, 2021

• Expiration Date Extension for Dextran 40 (10% LMD in 0.9% Sodium Chloride Injection) Lot 07011JT through June 1, 2022

September 30, 2021

• Coppertone® Issues Voluntary Nationwide Recall of Specific Lots of Aerosol Sunscreen Spray Products Due to the Presence of Benzene

October 1, 2021

• Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene

October 8, 2021

• Do Not Use Needle-Free Devices for Injection of Dermal Fillers

October 12, 2021

• Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency

October 14, 2021

• Lupin Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity

October 19, 2021

• Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect Strength

October 20, 2021

• Merck Issues Voluntary Nationwide Recall of Cubicin (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles

October 27, 2021

• artnaturals® Issues Voluntary Recall of Limited Batches of 8oz Bottles of Scent Free Hand Sanitizer Due to Presence of Impurities

November 2, 2021

• Drug Safety Communication: Alcohol-based Hand Sanitizer - Getting in the Eyes Can Cause Serious Injury

November 15, 2021

• SterRx, LLC Issues Voluntary Nationwide Recall of Certain SterRx Products

November 17, 2021

• Odor-Eaters® Issues Voluntary Nationwide Recall of Specific Lots of Odor- Eaters® Spray Powder and Odor-Eaters® Stink Stoppers® Spray Due to Benzene Contamination

November 22, 2021

• Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance

December 2, 2021

• Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping

December 3, 2021

• Gilead Issues A Voluntary Nationwide Recall Of Two Lots Of Veklury® (Remdesivir) Due To Presence Of Glass Particulates

December 4, 2021

• Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

December 7, 2021

• Teligent Pharma, Inc. Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potency

December 10, 2021

• Efficient Laboratories, Inc. Expands Voluntary Recall to Consumers to Include 12 Additional Lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM

December 27, 2021

• Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System

December 28, 2021

• Viona Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg Due to the Detection of NDMA Impurity

December 30, 2021

• Taro Pharmaceuticals Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 Due to Microbial Contamination