FDA Recall WatchDrug Liability Product Liability Product Recall on March 17, 2020
The U.S. Food and Drug Administration (FDA) is the federal government agency responsible for regulating not only food and drugs but also biologics (things like vaccines, blood, and tissue), medical devices (like breast implants or knee replacements), and even tobacco, cosmetics, microwave ovens, and pet food. The FDA is charged with protecting public safety and health when it comes to these products. When necessary as part of its duties, the agency must occasionally make sure that some of these unsafe products are removed from public circulation through its recall process.
Understanding FDA Recalls of Drugs and Medical Devices
An FDA recall of a drug or medical device is the often voluntary action of a company to correct and/or remove a medicine or product from public circulation because it’s in violation of the laws and regulations that the FDA is charged with enforcing. The nature of the violation may or may not be dangerous. But sometimes they’re deadly. Recalls are an important tool that the government uses to protect the public.
How the FDA Determines Recalls
A defective drug or medical device can be placed on the FDA recall list simply for being in violation of the law or regulations, even if it isn’t known to be dangerous. Although most recalls are voluntary, the FDA is responsible for overseeing how the drug or medical device recall is conducted, assessing the scope of the problem, making sure the violator’s actions are adequate, and classifying the recall according to seriousness. For instance, when evaluating a company’s medical device recall strategy, the FDA considers several factors, including (but not limited to):
- Results of a health hazard evaluation assessing the extent of any harm done, to whom, for how long.
- How well the product being recalled can be identified.
- How obvious it is to the general public that the recalled product is deficient.
- How much the product is used or unused in the market.
- Making sure essential products remain available.
What’s the difference between Class I, II, and III recalls?
FDA recalls fall into one of three medical device and drug recall classes, which reflect the danger posed to the public by the product that’s in violation.
- Class I recall: This is the most serious of the medical device and drug recall classes. This category is for dangerous or defective products that could reasonably be expected to cause serious adverse health problems or even death.
- Class II recall: Products in this category might cause temporary or medically reversible health problems, but the likelihood of severe danger is remote.
- Class III recall: It’s unlikely that products in this category will cause any adverse health problems. They are simply in violation of a law or regulation enforced by the FDA.
Have you suffered after using a drug or medical device on the FDA recall list? Call McIntyre Law to start your case today! (877) 917-5250
Recent FDA Recalls
Not all FDA recalls are given press releases or are posted on the FDA recall list on the agency’s website. However, important information is posted regularly. McIntyre Law believes this to be a vital service to the public. Knowing what medication is recalled or which medical devices are defective can prevent further harm to patients. Here, we list some of the most important recent FDA recalls that the public should know about.
August 2020 FDA Recalls
- All lots of Always Be Clean Hand Sanitizer and Just Hand Sanitzer that have been labeled to contain methanol have been recalled by Open Book Extracts for being mislabeled.
- Mylan Tranexamic Acid and Amiodarone HCl Injections have been recalled by Mylan N.V. because of vials potentially packaged in incorrect cartons.
- Harmonic Nature Hand Sanitizer has been recalled by Harmonic Nature S. de R.L. Mi due to the potential presence of 1-propanol.
- Zanilast+ Hand Sanitizer Gel has been recalled by Nanomateriales, S.A. de C.V. due to the undeclared presence of 1-propanol.
- V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel, and Protz Real Protection Antibacterial Hand Sanitizer have been recalled by Asiaticon S.A. de C.V. due to the possible presence of methanol and sub-potent ethanol levels.
- Medfusion 3500 and 4000 Syringe Pumps have been recalled by Smiths Medical due to a software error that may cause an over- or under-delivery of medications.
- Florence Morris Antiseptic Hand Sanitizer has been recalled by Grupo Asimex de Mexico S.A. de C.V. due to possible methanol contamination and sub-potent ethanol content.
- Metformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750 mg, have been recalled by Bayshore Pharmaceuticals, LLC due to unsafe levels of the impurity N-Nitrosodimethylamine (NDMA).
- Nuuxsan, Modesa, Assured & Next Hand Sanitizers have been recalled by ALBEK de Mexico S.A. de C.V. due to the undeclared presence of methanol, or wood alcohol.
- Goldenseal Root Powder has been recalled by Maison Terre due to microbial contamination.
- Yacana Hand Sanitizer, 70% alcohol content, has been recalled by Grupo Yacana México S.A.S de C.V. due to potential methanol contamination and sub-potent ethanol content.
- Heparin Sodium Compounded products have been recalled by SCA Pharmaceuticals due to the presence of the undeclared preservative benzyl alcohol.
- SkinGuard24 Hand Sanitizer has been recalled by SG24 LLC due to an indication of methanol presence on the label.
- ChloraPrep™ 3 mL applicators have been recalled by Becton, Dickinson and Company (BD) due to a potential fungal contamination.
- Bersih Hand Sanitizer Gel (fragrance-free) has been recalled by Soluciones Cosmeticas due to the potential presence of methanol.
- Gelbac T Antibacterial Hand Gel has been recalled by Incredible Products S.A. de C.V. due to possible methanol contamination.
- BodyGuard Infusion Pump Systems have had their April 2020 recall updated by CME America due to medication infusion errors.
- DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL have been recalled by Ferring Pharmaceuticals US due to higher-than-specified amounts of desmopressin.
- Command Brands Gel AntiBac Instant Hand Sanitizer has been recalled by Roque Plast S.A. de C.V. due to the potential presence of methanol.
- Jaloma Antiseptic Hand Sanitizer has been recalled by Laboratorios Jaloma S.A. de C.V. due to the presence of undeclared methanol, or wood alcohol.
July 2020 FDA Recalls
- Herbacil Antiseptic Hand Sanitizer, 70% alcohol, has been recalled by Broncolin S.A. de C.V due to potential methanol contamination.
- Assured, Blumen & Modesa Hand Sanitizer has been recalled by 4e Brands North America due to undeclared methanol, or wood alcohol.
- Resource Recover & Trading Hand Sanitizer has been recalled by Resource Recover & Trading LLC due to undeclared methanol subpotency ethyl alcohol.
- Born Basic, Scent Theory, et. al. Hand Sanitizer has been recalled by Real Clean Distribuciones SA de CV due to undeclared methanol.
- Shine & Clean Hand Sanitizer Gel has been recalled by Maquiladora Miniara, S.A. de C.V. due to the potential presence of methanol, or wood alcohol.
- Dexmedetomidine Hydrochloride Injection, 200 mcg/50ml, has been recalled by Fresenius Kabi Issues due to cross-contamination of lidocaine.
- Optimus Hand Sanitizer has been recalled by LIQ-E S.A. de C.V. due to potential methanol contamination.
- GlideScope Core One TouchSmart Cable (“OneTouch cable”) has been recalled by Verathon Inc. due to partial or complete loss of image during use.
- bio aaa Advance Hand Sanitizer has been recalled by AAA Cosmetica, S.A. de C.V. due to potential undeclared methanol contamination.
- Bersih Hand Sanitizer Gel Fragrance Free has been recalled by Soluciones Cosmeticas due to potential undeclared methanol contamination.
- Blumen Advanced Hand Sanitizer has been recalled by 4e Brands North America due to the potential presence of methanol, or wood alcohol.
- Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg, have been recalled by Lupin Pharmaceuticals Inc. due to an N-Nitrosodimethylamine (NDMA) impurity.
- BodyGuard® Infusion System Administration Sets have been recalled by CME America due to potential overinfusion or underinfusion during use.
- Ovation iX system has been recalled by Endologix® Inc. due to a weak material adjacent to the polymer fill causing leaks.
- Daptomycin for Injection, 500 mg/vial, has been recalled by Mylan Institutional LLC due to the presence of particulate matter.
- All Clean Hand Sanitizer, Moisturizer, and Disinfectant have been recalled by ITECH 361 due to the potential presence of methanol, or wood alcohol.
- Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, have been recalled by Granules Pharmaceuticals Inc. due to an N-Nitrosodimethylamine (NDMA) impurity.
- Arrow AutoCAT®2 and AC3 Optimus® Intra-Aortic Balloon Pump Series have been recalled by Arrow International Inc. due to possible breakdown of motor connector wires.
June 2020 FDA Recalls
- Saniderm Advanced Hand Sanitizer, 70% alcohol content, has been recalled by UVT INC. due to the potential presence of methanol, or wood alcohol.
- TTDeye colored contact lenses have been recalled by Chengdu Ai Qin E-commerce Co. Ltd due to distribution without FDA clearance.
- Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough have been recalled by GSK Consumer Healthcare because of incorrect dosing cups.
- Metformin Hydrochloride Extended-Release Tablets, USP 500mg, have been recalled by Lupin Pharmaceuticals Inc. due to an N-Nitrosodimethylamine (NDMA) impurity.
- Metformin Hydrochloride Extended-Release Tablets, USP 500mg, have been recalled by Apotex Corp. due to an N-Nitrosodimethylamine (NDMA) impurity.
- Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg, have been recalled by Teva Pharmaceuticals USA Inc. due to an N-Nitrosodimethylamine (NDMA) impurity.
- Metformin Hydrochloride Extended-Release Tablets, USP 500mg, have been recalled by Marksans Pharma Limited, India due to an N-Nitrosodimethylamine (NDMA) impurity.
- Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg, have been recalled by Amneal Pharmaceuticals LLC due to an N-Nitrosodimethylamine (NDMA) impurity.
- Biocell textured breast implants and tissue expanders have been recalled by Allergan Aesthetics due to an increased risk of BIA-ALCL.
May 2020 FDA Recalls
- HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief have been recalled by Medtronic due to the risk of breaks and tears during assembly.
- 30-mg, 60-mg and 90-mg NP Thyroid® have been recalled by Acella Pharmaceuticals LLC due to super potency.
- Python Embolectomy Catheters, Bard Embolectomy Catheters, and the OTW Latis Cleaning Catheters have been recalled by Applied Medical due to the risk of catheter tips detaching during use.
- Finasteride Plus 1.25mg capsules have been recalled by MasterPharm LLC due to the presence of an undeclared antihypertensive drug called minoxidil.
April 2020 FDA Recalls
- Langston Dual Lumen Catheters have been recalled by Vascular Solutions Inc. due to the risk of inner catheter separation during use.
- Infusion pumps and infusion sets have been recalled by CME America due to under-delivery of fluid and inaccuracy of pump delivery speed.
- R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe has been recalled by QuVa Pharma, Inc. due to presence of particulate matter.
- TRUE METRIX® AIR Blood Glucose Meter has been recalled by Trividia Health Inc. because of an incorrect factory-set unit of measure.
- Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL have been recalled by Fresenius Kabi USA LLC due to presence of particulate matter.
- Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container have been recalled by Braun Medical Inc. because of elevated levels of high molecular weight polymers.
- Tetracycline HCl Capsules, 250mg and 500mg, have been recalled by Avet Pharmaceuticals Labs Inc. because of low dissolution results.
- Nizatidine Oral Solution 15 mg/mL has been recalled by Amneal Pharmaceuticals LLC because of an NDMA (Nitrosodimethylamine) impurity.
- Methylprednisolone Sodium Succinate for Injection, USP 40mg, 125mg, and 1g have been recalled by Sagent Pharmaceuticals because of an unidentified impurity.
- Hydromorphone HCL Injection, USP CII have been recalled by Hospira Inc. because of the potential for empty or cracked glass vials.
- Imager II 5F Angiographic Catheters have been recalled by Boston Scientific Corporation because the catheter tip could potentially become detached, which could lead to serious injury or even death.
- LeMaitre Over the Wire Embolectomy Catheters have been recalled by LeMaitre Vascular Inc. because of balloon deflation and separation issues.
- All prescription and over-the-counter ranitidine drugs from all manufacturers, including the common brand name Zantac, have been withdrawn entirely from the U.S. market at the request of the FDA.
March 2020 FDA Recalls
- Pipeline flex embolization devices have been recalled by Medtronic because of a fracturing risk.
- STAT-Check and Medline resuscitator bags have been recalled by SunMed Holdings because they were defective.
- Phytonadione injectable emulsion USP, 10 mg/mL, single-dose ampules have been recalled by Dr. Reddy’s Laboratories, Ltd. because the ampules were breaking and shattering.
- Organic kudzu root herbal supplements have been recalled by Mountain Rose Herbs because of a potential salmonella contamination.
- Natural Remedies Active Male capsules have been recalled by the Natural Remedy Store because of the presence of undeclared Tadalafil.
- Ketorolac Tromethamine Injections at 30mg has been recalled by Hikma Pharmaceuticals USA Inc. because of the potential presence of small particulates.
February 2020 FDA Recalls
- Phenytoin Oral Suspension of 125 mg has been recalled by Taro Pharmaceuticals U.S.A., Inc. because of possible underdosing or overdosing of the drug.
January 2020 FDA Recalls
- Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid have been recalled by Efficient Laboratories, Inc. because of microbial contamination.
- Lamotrigine Tablets of 100mg have been recalled by Taro Pharmaceuticals U.S.A., Inc. because of cross-contamination with another drug substance, Enalapril Maleate.
- Nizatidine Capsules of 150mg and 300mg have been recalled by Mylan N.V. because of an NDMA (Nitrosodimethylamine) impurity.
December 2019 FDA Recalls
- Mirtazapine Tablets of 7.5mg strength have been recalled by Aurobindo Pharma USA, Inc. because of a label error for declared strength.
- Levetiracetam Oral Solution has been recalled by Lannett Company, Inc. because of microbial contamination of Bacillus subtilis.
- Men’s sexual supplements Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, Panther Platinum 30000 have been recalled by Motto International Corp because of the presence of undeclared Tadalafil.
November 2019 FDA Recalls
- Blood administration kits have been recalled by B. Braun Medical, Inc. because of a potential leakage at the joint between the blood filter and tubing.
- Ranitidine (commonly known under the brand name Zantac) has been recalled by multiple companies due to a potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA. Given the popularity of the drug, this is one of the most significant medication recalls of the year.
Learn more about this Zantac recall on FDA.gov and Health.Harvard.edu.
- Silver Bullet male enhancement capsules have been recalled by Nature’s Rx due to an unapproved active ingredient (sildenafil).
- Up2 libido and dietary supplements have been recalled by Med Man Distribution because the product is tainted with sildenafil.
- Viatrexx sterile injectable products have been recalled by Viatrexx Bio Incorporated because of a lack of sterility assurance.
- Fagron Let’s Gel Kit Convenience Packs have been recalled by Fagron Inc. because they potentially contain microbial contamination in the nonsterile Saturagel.
View more recalls on FDA.gov
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