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Food & drugs

Mass Spectrometers by Sciex: Safety Communication - Incorrect Assignment of Test Results

01-09-2016

Health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices, which may lead to serious adverse health consequences.

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Magic Gourmet Trading Inc. Issues Allergy Alert on Undeclared Allergens in “Koi Palace Mooncakes”

01-09-2016

Magic Gourmet Trading Inc. of Millbrae, CA is recalling all Koi Palace Mooncake products purchased in August 2016 because these items do not contain proper labeling of ingredients and possible allergens. Mooncake products manufactured by Magic...

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Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleed

01-09-2016

Reports of intraoperative or postoperative bleeding and hematomas, some of which required additional intervention, and three patient deaths potentially related to this issue that occurred shortly after carotid endarterectomy surgery.

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Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Ser

31-08-2016

Combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system has resulted in serious side effects, including slowed or difficult breathing and deaths.

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Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

30-08-2016

UPDATED 08/30/2016. Company press release with additional information added. Recall expanded to include all lots of DHZC-2 tablets.

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Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards

29-08-2016

Patients could take less than their intended lamotrigine dose, which may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.

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Willis Ocean Inc. Issues Allergy Alert on Undeclared Sulfites in Willis Eagle Brand Mut Gung Sweetened Ginger

26-08-2016

Willis Ocean Inc. of Brooklyn, NY, is recalling 30 cases of Willis Eagle brand MUT GUNG SWEETENED GINGER, because it contains undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic...

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Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates

25-08-2016

Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.

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Baptista’s Bakery Issues Allergy Alert on Undeclared Milk in Snack Factory® Original Pretzel Crisps®

23-08-2016

Baptista’s Bakery, Inc. announced a voluntary recall of a limited number of 7.2 oz. Snack Factory® Original Pretzel Crisps® and 7.2 oz Snack Factory® Sriracha Lime Pretzel Crisps® packages because they may contain undeclared milk ingredients. ...

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Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination

22-08-2016

Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.

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Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter

19-08-2016

Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.

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Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister P

18-08-2016

Risk of sub-therapeutic dose as well as potential microbial contamination.

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

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

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