FDA Alerts Archive for 2020

January 7, 2020

• Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

January 8, 2020

• Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient
• Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-Nitrosodimethylamine (NDMA) Impurity

January 10, 2020

• Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

January 14, 2020

• Drug Safety Communication: Belviq, Belviq XR (lorcaserin) - Due to Possible Increased Risk of Cancer

January 16, 2020

• FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

January 28, 2020

• Drug Safety Communication: Clozapine (Clozaril, Fazaclo ODT, Versacloz) - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems

January 31, 2020

• Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

February 13, 2020

• Drug Safety Communication: Belviq, Belviq XR (lorcaserin) by Eisai - FDA Requests Withdrawal of Weight-Loss Drug

February 21, 2020

• Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5mL Due to Possible Underdosing or Overdosing

February 27, 2020

• American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

March 4, 2020

• FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast
• Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis

March 16, 2020

• Natural Remedy Store Issues Voluntary Worldwide - Recall of Active Male Due to Presence of Undeclared Tadalafil

March 20, 2020

• Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

March 24, 2020

• FDA Alerts Patients and Health Care Professionals of EpiPen Auto-Injector Errors Related to Device Malfunctions and User Administration

March 26, 2020

• Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

April 1, 2020

• FDA Requests Removal of All Ranitidine Products (Zantac) From the Market

April 10, 2020

• Ivermectin Intended for Animals: FDA Warns - Do Not Use in Humans as a Treatment for COVID-19

April 13, 2020

• Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash Due to Complaints Received on Potential Product Contamination which Compromises Sterility
• Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events
• Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling

April 15, 2020

• Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA

April 16, 2020

• Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications

April 20, 2020

• B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers
• Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

April 23, 2020

• FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction

April 24, 2020

• Drug Safety Communication: Hydroxychloroquine or Chloroquine for COVID-19 - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems

April 28, 2020

• GSK Consumer Healthcare Recalls Benefiber Healthy Shape Prebiotic Fiber Supplement and Benefiber Prebiotic Fiber Supplement Due to Possible Plastic Contamination from the Bottle Cap

May 8, 2020

• ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter

May 11, 2020

• MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug

May 20, 2020

• Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval

May 22, 2020

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

June 1, 2020

• Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity
• FDA Alerts Patients and Health Care Professionals of Amneal and Impax Laboratories Epinephrine Auto-Injector Device Malfunctions

June 3, 2020

• CDER Alert: Two Neuromuscular Blocking Agents - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps

June 5, 2020

• Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500 mg Due to the Detection of N-nitrosodimethylamine (NDMA)
• Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)
• Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

June 11, 2020

• Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)

June 15, 2020

• Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment

June 18, 2020

• GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

June 19, 2020

• FDA Advises Consumers Not To Use Hand Sanitizer Products Manufactured by Eskbiochem

July 6, 2020

• Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

July 7, 2020

• Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate
• FDA Warns Consumers of Risk of Methanol Contamination in Certain Hand Sanitizers

July 8, 2020

• Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

July 22, 2020

• Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

July 23, 2020

• Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing

July 27, 2020

• FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

July 31, 2020

• Hand Sanitizers: FDA Updates on Recalls Due to Dangerous, Potential Presence of Methanol and Subpotent Products

August 5, 2020

• Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency

August 12, 2020

• FDA Expands Hand Sanitizer Warnings to Include 1-Propanol Contamination

August 18, 2020

• SCA Pharmaceuticals (SCA) Is Issuing a Voluntary Nationwide Recall of Heparin Sodium Compounded Products Due to Incorrect Preservative (Benzyl Alcohol)

August 20, 2020

• Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

August 27, 2020

• COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers

August 31, 2020

• Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up

September 1, 2020

• The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet Due to the Presence of Undeclared Sildenafil

September 3, 2020

• RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency
• Corgiomed LLC Issues Voluntary Nationwide Recall of All Lots of Leafree Instant Hand Sanitizer Aloe Vera Labeled as EDIBLE ALCOHOL

September 8, 2020

• FDA Alerts Health Care Professionals and Oncology Clinical Investigators About Efficacy and Potential Safety Concerns with Atezolizumab in Combination with Paclitaxel for Treatment of Breast Cancer

September 17, 2020

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

September 21, 2020

• FDA Alerts of Perrigo's Voluntary Albuterol Inhaler Recall

September 23, 2020

• Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Riomet ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
• Drug Safety Communication: Benzodiazepine Drug Class - Boxed Warning Updated to Improve Safe Use

September 24, 2020

• Drug Safety Communication: Benadryl (diphenhydramine) - Serious Problems with High Doses of the Allergy Medicine

October 5, 2020

• Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

October 15, 2020

• Drug Safety Communication: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later

October 28, 2020

• Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

November 2, 2020

• Nostrum Laboratories, Inc. Issues 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

November 3, 2020

• Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

November 9, 2020

• Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

November 19, 2020

• Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

December 2, 2020

• MPM Medical LLC Issues Voluntary Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepecia Contamination

December 3, 2020

• FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection

December 9, 2020

• Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure
• AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

December 23, 2020

• Shane Erickson, Inc. DBA Innovative Marketing Consultants Issues Voluntary Nationwide Recall of Wash-Free Hand Sanitizer Due to Potential Presence of Undeclared Methanol

December 28, 2020

• Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

December 31, 2020

• Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination