Food & drugs

Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

12-01-2018

CORRECTION to January 11, 2018 letter. Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement.

Rico Brand Issues Allergy Alert on Undeclared Soy in Tofu Breakfast Burrito

12-01-2018

Rico Brand of Salt Lake City, Utah is recalling Tofu Breakfast Burrito, because it may contain undeclared Soy. People who have an allergy or severe sensitivity to Soy run the risk of serious or life-threatening allergic reaction if they consume...

Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced

12-01-2018

General use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products.

Fieldbrook Foods Corporation Clarifies Scope of its Voluntary Recall. Products Include Orange Cream

12-01-2018

Fieldbrook Foods Corporation is clarifying that the previously announced voluntary recall of all orange cream bars and chocolate coated vanilla ice cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, NY plant (plant...

Hom/Ade Foods, Inc. Voluntarily Recalls Frozen Biscuits Because of Possible Health Risk

12-01-2018

Hom/Ade Foods, Inc is voluntarily recalling Mary B’s® brand biscuits due to potential contamination with Listeria monocytogenes. The problem was discovered in a product sampling conducted by an outside co-packer, who manufactured the product.

Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Du

11-01-2018

January 10, 2018 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of...

Gilster - Mary Lee Corp. Issues a Recall For Undeclared Milk Allergen in Essential Everyday® Chicken Coating

11-01-2018

January 8, 2018 - Gilster-Mary Lee, 520 Old St. Mary’s Road, of Perryville, Missouri, is voluntarily recalling one lot of Essential Everyday® Coat & Bake Original Chicken coating, UPC 41303-01572 at the consumer level because it may contain...

Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow

11-01-2018

An embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.

Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

11-01-2018

Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death.

Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes

11-01-2018

Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.

Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

11-01-2018

Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.

International Laboratories, LLC Issues Voluntary Nationwide Recall of one (1) Lot of Clopidogrel Tablets USP, 75 mg packaged in

10-01-2018

International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may...

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Food & drugs

Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

Rico Brand Issues Allergy Alert on Undeclared Soy in Tofu Breakfast Burrito

Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced

Fieldbrook Foods Corporation Clarifies Scope of its Voluntary Recall. Products Include Orange Cream

Hom/Ade Foods, Inc. Voluntarily Recalls Frozen Biscuits Because of Possible Health Risk

Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Du

Gilster - Mary Lee Corp. Issues a Recall For Undeclared Milk Allergen in Essential Everyday® Chicken Coating

Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow

Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes

Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

International Laboratories, LLC Issues Voluntary Nationwide Recall of one (1) Lot of Clopidogrel Tablets USP, 75 mg packaged in

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

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