Food & drugs

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hos

04-06-2018

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Label

04-06-2018

FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.

Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites

02-06-2018

Sanders announced today that it is recalling its 3.75oz Milk Chocolate Covered Fudge Mini Bites because they may contain undeclared almonds. People who have allergies to almonds run the risk of serious or life-threatening allergic reaction if they...

SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits

01-06-2018

SDQ Trading Inc. of 651A Lexington Ave, Brooklyn, NY 11221 is recalling its 16.5 oz packages of Cheese Biscuits because they may contain undeclared milk allergen. Consumers who are allergic to milk allergen may run the risk of serious or...

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags

01-06-2018

On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may...

HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power

01-06-2018

Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.

STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings: Recall - Patient Port May Detach During Use

01-06-2018

The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use.

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

31-05-2018

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could...

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

31-05-2018

The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays D

31-05-2018

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found...

H-E-B Voluntarily Issues Recall Specific flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Cr

31-05-2018

Committed to the quality of its products, H-E-B is voluntarily issuing an all-store recall for certain flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets for broken metal in processing equipment...

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out

29-05-2018

Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active...

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Food & drugs

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hos

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Label

Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites

SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags

HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power

STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings: Recall - Patient Port May Detach During Use

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

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

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays D

H-E-B Voluntarily Issues Recall Specific flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Cr

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out

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UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

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