Image Español How to Choose a Smoking Cessation Product That’s Right for You Smoking cessation products approved or cleared by the U.S. Food and Drug Administration are shown to help people quit smoking and can even double your chance of quitting successfully. Are you or a loved one among those American adults who smoke cigarettes…
Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Medfusion Syringe Infusion Pumps Models, Product Codes, and Software Versions: See Recall Database Entries Devices Recalled in the U.S.: 118,055 Dates distributed: October 2004 to…
Albertsons Companies Voluntarily Recalls Select ReadyMeals Seafood Products Due to Undeclared Allergens
ReadyMealsShrimpCooked withCocktailSauce 12oz Crustacean(Shrimp),Fish(Anchovy) Clear plastic container with four compartments 23463800000 All SellThru Dates up to and including July 18 ACME,Albertsons,Andronico’sCommunityMarkets,Balducci’s,CarrsSafeway,Eagle, JewelOsco, King’s,Pak ‘N Save, Safeway,Shaw’s, StarMarket, Vons AK, CA, CO, CT,DE, ID,IL, IA,ME,MD,MA, NE, NH, NV,NJ, NM,NY, PA,RI, SD,VT, VA,WA, DC,WY ReadyMealsSnow CrabLegsImitationSurimi 12oz Crustacean(Crab), Egg,Fish(PollockWhiting,Anchovy),Wheat Clear plastic container with four compartments 23463900000 All…
MKS Enterprise LLC Voluntary Recalls of Dose Vital VIP Vital Honey Due to Presence of Undeclared Tadalafil
Summary Company Announcement Date: July 18, 2022 FDA Publish Date: July 19, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared active pharmaceutical ingredient tadalafil Company Name: MKS Enterprise LLC Brand Name: Brand Name(s) Dose Vital Product Description: Product Description Company Announcement This product was found to contain the undeclared active pharmaceutical ingredient…
FDA D.I.S.C.O.: Burst Edition: FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On March 23, 2022, the FDA approved Pluvicto (active ingredient…
Sweet Loren’s, Inc Issues Voluntary Allergy Alert On Undeclared Gluten in Product
Summary Company Announcement Date: July 16, 2022 FDA Publish Date: July 18, 2022 Product Type: Food & Beverages Bakery Product/Mix Allergens Reason for Announcement: Recall Reason Description Undeclared gluten Company Name: Sweet Loren’s Brand Name: Brand Name(s) Sweet Loren’s Product Description: Product Description Sugar cookie dough Company Announcement Sweet Loren’s of New York, NY is…
For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
Date Issued: July 15, 2022 The U.S. Food and Drug Administration (FDA) is advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox…
URGENT: Nationwide Voluntary Recall of Natierra Organic Freeze- Dried Blueberry (lot # 2021363-1 & 2022026-1) Due to levels of Lead
Summary Company Announcement Date: July 14, 2022 FDA Publish Date: July 14, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Freeze Dried Blueberry Company Name: BrandStorm Inc. Brand Name: Brand Name(s) Product Description: Product Description Freeze Dried Blueberry Company Announcement BrandStorm Inc. announced it is voluntarily recalling 2 lots of Organic…
Crown Prince, Inc. Issues Voluntary Recall of Smoked Baby Clams in Olive Oil Due to the Presence of Detectable Levels of PFAS Chemicals
Summary Company Announcement Date: July 15, 2022 FDA Publish Date: July 15, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Detectable levels of per-and polyfluoroalkyl substances (PFAS) Company Name: Crown Prince Brand Name: Brand Name(s) Crown Prince Product Description: Product Description Smoked Baby Clams in Olive Oil Company Announcement CROWN PRINCE,…
Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
Summary Company Announcement Date: July 15, 2022 FDA Publish Date: July 15, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination with Gluconacetobacter liquefaciens Company Name: Vi-Jon, LLC Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor Company Announcement July 14, 2022…