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FDA MedWatch Alerts

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

July 10, 2018

Audience: Patient, Health Professional, Pharmacy. ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or... Read more

Kratom (mitragyna speciosa) powder products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

June 22, 2018

Audience: Consumer, Health Professional. ISSUE: The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines. The affected products (listed below) can be identified by Lot No.: 0102031800 and Batch No.: 031800. Specifically,... Read more

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events After Receiving Eye Injections

June 15, 2018

Audience: Patient, Health Professional, Eye Care, Risk Manager. ISSUE:  At least 43 patients reported adverse events after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in be... Read more

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpujectâ„¢ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

June 4, 2018

Audience: Pain Management, Pharmacy, Anesthesiology, Emergency Medicine, HealthProfessional. ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate... Read more

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

May 31, 2018

Audience: Patient, Pharmacy, Health Professional. ISSUE: The Fluticasone Propionate Nasal Spray 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint. There is a potential for patients to be exposed to the glass particles and mechanical irritation... Read more

Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

May 29, 2018

Audience: Patient, Pharmacy, Health Professional. ISSUE: Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of Taytulla and the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at... Read more

X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination

May 29, 2018

[Posted 05/29/2018] AUDIENCE: Consumer ISSUE: The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals. Distributor Product Description Herb-X Solutions X-Jow Pain Gel, 4oz. X-Jow Pain Gel, 8oz. United Exchange Acne Shave Moisturizer, 3.3 oz. Acne Shave Shave Cream with Acne... Read more

95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol

May 23, 2018

Audience: Consumer. ISSUE: Lake Michigan Distilling Company, LLC of La Porte, Indiana, doing business as Ethanol Extraction, is recalling its 95% Ethyl Alcohol product (“Product”) because of possible contamination with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals. Recall of the Product was sparked by news that a man in Massachusetts all... Read more

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder

May 23, 2018

Audience: Pediatrics, Dentistry, Consumer, Health Professional, Pharmacy. ISSUE: The FDA is warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label. These... Read more

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

May 21, 2018

Audience: Consumer,  Health Professional, Pharmacy. ISSUE: MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls. Manufacturing products ... Read more

Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects

May 18, 2018

Audience: Infectious Disease, Health Professional, Patient. ISSUE: Serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or... Read more

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

May 18, 2018

Audience: Oncology, Pharmacy, Risk Manager. ISSUE: FDA is alerting health care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of... Read more

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

May 18, 2018

[Posted 05/18/2018] AUDIENCE: Consumer ISSUE: FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active... Read more

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

May 10, 2018

Audience: Consumer, Health Professional, Patient. ISSUE: CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, also commonly called B. cepacia, in three states: California (2), Pennsylvania (7), and New Jersey (1). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been... Read more

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

May 8, 2018

Audience: Risk Manager, Infectious Disease, Pharmacy, Nursing. ISSUE: AuroMedics Pharma is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose vials, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the... Read more

Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter

May 8, 2018

Audience: Risk Manager, Infectious Disease, Pharmacy, Nursing. ISSUE: AuroMedics Pharma is voluntarily recalling two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been... Read more

Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

April 25, 2018

Audience: Health Professional, Patient, Pharmacy. ISSUE: The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated q... Read more

NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination

April 19, 2018

Audience: Consumer. ISSUE: NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. One illness has been reported to date and... Read more

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

April 19, 2018

Audience: Consumer. ISSUE: Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea... Read more

Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil

April 18, 2018

Audience: Consumer. ISSUE: AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction. AMA Wholesale Inc. has not received any reports of adverse events related to this... Read more

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FDA MedWatch Alerts Archive