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FDA MedWatch Alerts

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

May 22, 2018

[Posted 05/22/2018] AUDIENCE: Cardiology, Critical Care Medicine, Nursing, Risk Manager, Surgery ISSUE: The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to s... 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

Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil

April 18, 2018

Audience: Consumer. ISSUE: Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase... Read more

Coastal Meds to Recall All Products Marketed as Sterile

April 13, 2018

Audience: Pharmacy, Nursing, Risk Manager. ISSUE: FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection. BACKGROUND: During FDA’s recent inspection of Coastal Meds, investigators observed visible particulates and poor sterile production practices which further raise c... Read more

Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance

April 12, 2018

Audience: Pharmacy, Nursing . ISSUE: Premier Pharmacy Labs is voluntarily recalling injectable products due to a potential lack of sterility assurance. Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the... Read more

Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella

April 10, 2018

Audience: Consumer. ISSUE: Club 13 is recalling 15-gram, 30-gram, 90-gram, 150-gram, and 454-gram pouches, and all bulk orders of "Maeng Da Red" kratom powder, lot # MRMD012618 5-count, 25-count, 50-count, 100-count, 120-count capsule, and all bulk capsule orders of “Maeng Da Red” kratom bottles, marked with the following lot numbers on the bottom left side: MRMD013018, MRMD013118, MRMD020118, MRMD020518, MRM... Read more

Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution

April 9, 2018

Audience: OBGYN, Patient, Risk Manager. ISSUE: The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information. On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare f... Read more

Kratom-containing Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella

April 3, 2018

Audience: Consumer. ISSUE: FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. Two samples of kratom products manufactured by Triangle P... Read more

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

April 3, 2018

Audience: Consumer. ISSUE: NutriZone, LLC is recalling 4 different dietary supplements because it has the potential to be contaminated with Salmonella. The potential for contamination was noted after routine sampling and testing by the FDA revealed the presence of Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with... Read more

Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination

April 2, 2018

Audience: Consumer, Pediatrics. ISSUE: MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. voluntarily recalled four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold ... Read more

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FDA MedWatch Alerts Archive