FDA Alerts Archive for 2019

January 3, 2019

• Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

January 5, 2019

• Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

January 8, 2019

• Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass
• Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil

January 18, 2019

• Prinston Pharmaceutical Inc. Issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodiethylamine (NDEA) in the Products

January 22, 2019

• UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

January 29, 2019

• Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDF-5 Inhibitors in the Product
• Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

February 1, 2019

• FDA Warns Patients and Doctors About Recall of Home-Use Test Strips Used with Device to Monitor Blood Thinner Warfarin, Not Authorized for Sale in U.S.
• FDA Warns Compounders Not to Use Glutathione from Letco Medical to Compound Sterile Drugs

February 4, 2019

• Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

February 21, 2019

• FDA Adds Boxed Warning for Increased Risk of Death with Gout Medicine Uloric (febuxostat)

February 22, 2019

• Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA Impurity

February 25, 2019

• Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein
• Safety Communication: Xeljanz, Xeljanz XR (tofacitinib) Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

February 28, 2019

• Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of NMBA Impurity found in the Active Pharmaceutical Ingredient

March 1, 2019

• AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine/Valsartan Tablets USP and Valsartan Tablets, USP Due to the Detection of NDEA Impurity
• Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

March 4, 2019

• Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

March 7, 2019

• American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

March 13, 2019

• Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

March 15, 2019

• Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API)
• Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API)

March 18, 2019

• Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

March 19, 2019

• Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API)

March 21, 2019

• Ata Int. Inc. Issues Voluntary Nationwide Recall of BLUEFUSION Capsules, due to presence of Undeclared Sildenafil, Tadalafil, Desmethyl carbodenafil, Dithiodesmethyl carbodenafil, Scutellarin and Daidzein
• FDA Warns About the Risks Associated with the Investigational Use of Venclexta in Multiple Myeloma

March 25, 2019

• USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil

April 3, 2019

• E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

April 9, 2019

• FDA Identifies Harm Reported from Sudden Discontinuation of Opioid Pain Medicines and Requires Label Changes to Guide Prescribers

April 18, 2019

• Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

April 19, 2019

• Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling

April 27, 2019

• Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredient (API)

April 29, 2019

• AmEx Pharmacy Issues Voluntary Nationwide Recall for one Lot of Bevacizumab 1.25mg/0.05mL 31 G Syringe Due to Reported Defective Delivery System
• Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply

April 30, 2019

• FDA Adds Boxed Warning for Risk of Serious Injuries Caused by Sleepwalking with Certain Prescription Insomnia Medicines

May 1, 2019

• Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance

May 3, 2019

• Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection, USP Due to the Presence of a Glass Fragment Observed in One Vial of Reconstituted Product
• Vivimed Life Sciences Pvt Ltd Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity

May 12, 2019

• Novartis Issues Voluntary Nationwide Recall of Promacta 12.5 mg for Oral Suspension Due to Potential Peanut Contamination

May 24, 2019

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

May 28, 2019

• Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) as a Result of a Sterility Test Failure

May 30, 2019

• Novis PR LLC Issues Voluntary Nationwide Recall of Pecgen DMX Due to a Labeling Error

June 11, 2019

• Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium to 50 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply, Inc.

June 13, 2019

• APS Biogroup Recalls Viralox, DPS Throat Spray, Immulox, and Immuno PRP Spray, Because of Possible Health Risk

June 21, 2019

• FDA Alerts Patients and Healthcare Professionals to Infusion Options’ Voluntary Recall Due to Quality Issues

June 25, 2019

• FDA Alerts Consumers Not to Use Kratom NC’s Products

June 26, 2019

• Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level Recall of Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg due to detection of NMBA Impurity

June 28, 2019

• FDA Warns Patients and Health Care Professionals Not to Use Sterile Products from Pacifico National Inc., dba AmEx Pharmacy
• PharMEDium Services, LLC Issues Voluntary Nationwide Recall of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe Due to Presence of Sulfite

July 2, 2019

• Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate

July 3, 2019

• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens

July 5, 2019

• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Wal Mart

July 10, 2019

• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At CVS

July 15, 2019

• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Manufactured and Distributed as Altaire Labeled Products

July 16, 2019

• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold by OCuSOFT
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Over-The-Counter Ophthalmic Products Sold By Natural Ophthalmics And TRP Company, Inc.

July 19, 2019

• Bayer Statement on Voluntary Recall of Two Lots of Kogenate FS Antihemophilic Factor (Recombinant) in the United States

July 23, 2019

• FDA Advises Patients Not to Use Herbal Doctor Remedies’ Medicines
• Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results

July 26, 2019

• FDA Approves Boxed Warning About Increased Risk of Blood Clots and Death with Higher Dose of Tofacitinib (Xeljanz, Xeljanz XR)

August 8, 2019

• Ridge Properties LLC DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of PRE-TAT , Superior Pain and Itch Relief, and Soothing Sore Relief Cream and Gel Products Due to Microbiological Contamination and Superpotency

August 13, 2019

• FDA Review Finds No Increased Risk of Prostate Cancer with Parkinson's Disease Medicines Containing Entacapone (Comtan, Stalevo)

August 15, 2019

• Pfizer Inc. Issues a Voluntary Nationwide Recall for 2 Lots of Relpax (eletriptan hydrobromide) 40 mg Tablets Due to Potential Microbiological Contamination of Non-Sterile Products

August 28, 2019

• FDA Warns About Rare Occurrence of Serious Liver Injury with Use of Hepatitis C Medicines Mavyret, Zepatier, and Vosevi in Some Patients with Advanced Liver Disease

August 30, 2019

• Pacifico National, Inc. dba AmEx Pharmacy Issues Voluntary Nationwide Recall for all Lots of Bevacizumab

September 5, 2019

• Takeda Issues US Recall of Natpara (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate

September 6, 2019

• Vaping Illnesses: Consumers Can Help Protect Themselves by Avoiding Tetrahydrocannabinol (THC)-Containing Vaping Products
• Hospira, Inc., Issues A Voluntary Nationwide Recall for One Lot of Bacteriostatic Water for Injection, USP, due to a Potential Lack of Sterility Assurance

September 9, 2019

• Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL due to Microbial Contamination

September 12, 2019

• KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility
• Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to a Labeling Error

September 13, 2019

• Safety Information: Ranitidine Generics - NDMA Found in Samples of Some Ranitidine Medicines
• Drug Safety Communication: Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) - Rare but Severe Lung Inflammation

September 16, 2019

• Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of Mero Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement Due to Presence of Active Ingredient Tadalafil

September 19, 2019

• Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP

September 20, 2019

• Drug Safety Communication: Imodium (loperamide) for Over-the-Counter Use - FDA Limits Packaging To Encourage Safe Use

September 23, 2019

• Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in the Product

September 25, 2019

• Apotex Corp. Issues Voluntary Recall of Ranitidine Tablets 75mg and 150mg Due to Detection of an Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in the Product

October 4, 2019

• Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street

October 10, 2019

• Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance

October 11, 2019

• FDA Advises Consumers Not to Use Rompe Pecho Cough Syrup

October 15, 2019

• Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance

October 18, 2019

• Johnson & Johnson Consumer Inc. to Voluntarily Recall a Single Lot of Johnson’s Baby Powder in the United States

October 22, 2019

• FDA, FTC Warn Company Marketing Unapproved Cannabidiol Products with Unsubstantiated Claims to Treat Teething and Ear Pain in Infants, Autism, ADHD, Parkinson’s and Alzheimer’s Disease
• GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil

October 23, 2019

• Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market
• Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.
• Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product

October 25, 2019

• Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
• Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

October 26, 2019

• Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance

October 30, 2019

• ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter

November 5, 2019

• UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

November 6, 2019

• Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity

November 8, 2019

• Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil
• American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

November 12, 2019

• Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

November 13, 2019

• FDA Updates on Angiotensin II Receptor Blocker (ARB) Recalls
• Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibitor Found in The Product

November 15, 2019

• Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

November 19, 2019

• Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

December 17, 2019

• Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

December 19, 2019

• FDA Warns About Serious Breathing Problems with Seizure and Nerve Pain Medicines Gabapentin (Neurontin, Gralise, Horizant) and Pregabalin (Lyrica, Lyrica CR) in Patients with Respiratory Risk Factors
• Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/mL Due to Microbial Contamination

December 31, 2019

• Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength