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FDA MedWatch Safety Alerts



Last Build Date: Fri, 23 Jun 2017 15:30:00 -0400

 



Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance

Fri, 23 Jun 2017 15:30:00 -0400

Reasonable probability that patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.



Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use

Fri, 23 Jun 2017 12:50:00 -0400

UPDATED 06/23/2017. All unexpired lots of the RX, OTW, and CS versions are recalled. Material in the patient's bloodstream can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.



Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance

Thu, 22 Jun 2017 15:20:00 -0400

Patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.






Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance

Fri, 16 Jun 2017 22:00:00 -0400

There is a reasonable probability that the patient may experience adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.



Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston: Recall - Sub Potency

Thu, 15 Jun 2017 00:00:00 -0400

An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient’s conditions. Posted 06/15/2017



Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance

Thu, 15 Jun 2017 00:00:00 -0400

A patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/16/2017



Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure

Thu, 15 Jun 2017 00:00:00 -0400

Failed dissolution could result in less drug being absorbed. Posted 06/15/2017



Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors

Thu, 15 Jun 2017 00:00:00 -0400

Accuracy errors may lead to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures Posted 06/15/2017



Topical Products by Phillips Company: Recall - Due to Concerns of Manufacturing Practices

Wed, 14 Jun 2017 15:42:00 -0400

The possibility of decreased quality and consistency of the product, may have an impact on the safety and efficacy of the product posing a risk to patients.



Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets

Tue, 13 Jun 2017 14:50:00 -0400

Patients should not stop taking Eliquis without consulting with their physician



LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results

Tue, 06 Jun 2017 07:00:00 -0400

UPDATED 06/06/2017. Class I Recall expanded. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.



SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet: Class I Recall - Potential for Harmful Chemicals

Tue, 30 May 2017 13:00:00 -0400

Higher than allowed levels of harmful chemicals may cause chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death. Posted 05/30/2017



Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.: Recall - Out of Sequence Tablets and Missing Expiry/Lot Information

Mon, 29 May 2017 19:25:00 -0400

Oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.



Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle

Fri, 26 May 2017 10:39:00 -0400

Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure.



Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients

Fri, 26 May 2017 08:19:00 -0400

Presence of sildenafil and tadalafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.



Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra

Thu, 25 May 2017 08:20:00 -0400

Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.



HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange

Tue, 23 May 2017 17:06:00 -0400

A slow or improper driveline changeover places certain patients at risk of serious injury or death.



Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients

Mon, 22 May 2017 14:50:00 -0400

Use or consumption of products containing SARMs and anabolic steroid-like substances may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products.



V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down

Mon, 22 May 2017 13:30:00 -0400

Unexpected stop in ventilation therapy may cause serious adverse health consequences, including death.