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Food & drugs

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...

Product safety

Target Recalls Infant Rompers Due to Choking Hazard

30-12-2020

 The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.

Product safety

Target Recalls Infant-Toddler Girl’s One-Piece Rashguard Swimsuits Due to Choking Hazard

30-12-2020

The snaps can break or detach from the suits, posing choking and laceration hazards to children.

Food & drugs

2020 Safety Communications

29-12-2020

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and...

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Food & drugs

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

17-01-2018

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection,...

Food & drugs

Bellisio Foods, Inc. Issues Allergy Alert Regarding Certain Michelina’s Fettuccine Alfredo Packages Due to Potential Presence o

16-01-2018

Bellisio Foods, Inc., a Jackson, Ohio, manufacturer, is voluntarily recalling certain Michelina’s Fettuccine Alfredo due to the possibility some...

Food & drugs

Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions

16-01-2018

Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping,...

Product safety

Fujifilm Recalls Power Adapter Wall Plugs Sold with Digital Cameras Due to Shock Hazard

16-01-2018

The power adapter wall plug can crack, break or detach and remain in the wall and expose live electrical contacts, posing a shock hazard.

Food & drugs

Hiland Dairy Announces Voluntary Recall Of Hiland Dairy Orange Juice And Tampico Citrus Punch

13-01-2018

Hiland Dairy is announcing a voluntary recall of two products produced at the Omaha, Nebraska facility, over concerns the products may contain milk...

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...

Food & drugs

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...

Food & drugs

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...

Food & drugs

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...

Food & drugs

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...

Product safety

Coldwater Creek Recalls Snow Globes Due to Fire Hazard (Recall Alert)

12-01-2018

Light refraction through the globes can singe or melt items in contact with or in the immediate proximity, posing a fire hazard.

Food & drugs

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...