Drug & Medical Device Recalls & Safety Alerts

Hospira Symbiq Infusion System Touchscreen: Class 1 Recall – May Not Respond to Selection

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Hospira Symbiq Infusion System Touchscreen: Class 1 Recall – May Not Respond to Selection. According to the Food & Drug Administration FDA’s MedWatch: Failure of touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery [...]

Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall – User Difficulty With Firing Stapler Devices

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall – User Difficulty With Firing Stapler Devices. According to the Food & Drug Administration FDA’s MedWatch: Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, [...]

New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak. According to the Food & Drug Administration FDA’s MedWatch: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate. For more information [...]

Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication – Reports of Serious Tissue Damage

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication – Reports of Serious Tissue Damage. According to the Food & Drug Administration FDA’s MedWatch: Incorrect use can cause hemorrhaging and soft [...]

Intestinomicina Dietary Supplement by Laboratorios Lopez: Safety Alert – Undeclared Drug Ingredient

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Intestinomicina Dietary Supplement by Laboratorios Lopez: Safety Alert – Undeclared Drug Ingredient. According to the Food & Drug Administration FDA’s MedWatch: Intestinomicina can interact with other medications consumers may be taking and may cause serious and life threatening injuries. For more information on [...]

Over-The-Counter Topical Muscle and Joint Pain Relievers: Drug Safety Communication – Rare Cases of Serious Burns

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Over-The-Counter Topical Muscle and Joint Pain Relievers: Drug Safety Communication – Rare Cases of Serious Burns. According to the Food & Drug Administration FDA’s MedWatch: Some of the burns had serious complications requiring hospitalization For more information on the drug or medical device [...]

Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall – Potential for Oversized Tablets

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall – Potential for Oversized Tablets. According to the Food & Drug Administration FDA’s MedWatch: Tablets from the affected lot may exceed the weight specification and could be super-potent for the ingredients Hydrocodone Bitartrate [...]

Nimodipine: Recall – Crystallization of Fill Material

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Nimodipine: Recall – Crystallization of Fill Material. According to the Food & Drug Administration FDA’s MedWatch: The product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency. For more information on the drug or [...]

I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall – Risk of Continuous Infusion at a Rate Greater Than Expected

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall – Risk of Continuous Infusion at a Rate Greater Than Expected. According to the Food & Drug Administration FDA’s MedWatch: Bolus Button may not lock in the down position when depressed and/or the [...]

EphBurn 25 Dietary Supplement by Brand New Energy: Recall – Undeclared Drug Ingredient

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: EphBurn 25 Dietary Supplement by Brand New Energy: Recall – Undeclared Drug Ingredient. According to the Food & Drug Administration FDA’s MedWatch: Adverse effects associated with ephedrine alkaloid-containing supplements may include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, psychosis, memory loss, [...]

Revatio (sildenafil): Drug Safety Communication – Recommendation Against Use in Children

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Revatio (sildenafil): Drug Safety Communication – Recommendation Against Use in Children. According to the Food & Drug Administration FDA’s MedWatch: Recent long-term clinical pediatric trial showed children taking a high dose of Revatio had a higher risk of death than children taking a [...]

Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall – Risk of Fluid Entry into Device Keypads

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall – Risk of Fluid Entry into Device Keypads. According to the Food & Drug Administration FDA’s MedWatch: Large variations in dosing of critical components in highly vulnerable patients could lead to serious [...]

CareFusion Alaris Pump Module Model 8100: Class I Recall – Motor Stalls During Infusion

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: CareFusion Alaris Pump Module Model 8100: Class I Recall – Motor Stalls During Infusion. According to the Food & Drug Administration FDA’s MedWatch: Motor stalls could result in a termination of infusion. For more information on the drug or medical device recall or [...]

CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall – Potential for Pump Malfunction To Stop Infusion

Drug & Medical Device Recalls & Safety Alerts

A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall – Potential for Pump Malfunction To Stop Infusion. According to the Food & Drug Administration FDA’s MedWatch: Risk of the pump module door keypad overlay to separate from the keypad assembly, which could [...]