Summary Company Announcement Date: October 19, 2021 FDA Publish Date: October 19, 2021 Product Type: Food & Beverages Soup Reason for Announcement: Recall Reason Description Potential for hard plastic opaque pieces Company Name: Ivar’s Soup and Sauce Company Brand Name: Brand Name(s) Product Description: Product Description Kettle Classic Clam Chowder with Uncured Bacon Company Announcement…
Cook Medical Issues Voluntary Recall of Transseptal Needle and Transseptal Needle with Catheter
Summary Company Announcement Date: October 18, 2021 FDA Publish Date: October 19, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Complaints of rust on the products Company Name: Cook Medical Brand Name: Brand Name(s) Cook Medical Product Description: Product Description Transseptal Needle and Transseptal Needle Catheter Company Announcement Bloomington, Ind. — On…
Hearing Aids and Personal Sound Amplification Products: What to Know
Image Español 简体中文 Are you or a loved one having a hard time hearing? Perhaps you’re thinking about getting a hearing aid. Hearing aid technology keeps evolving, which means there’s a growing variety of styles and features to consider. “People who already use a hearing aid know that selecting one is not a simple decision,” says…
Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication
Date Issued: October 12, 2021 The U.S. Food and Drug Administration (FDA) is informing patients and health care providers about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes. The FDA is aware of the potential for overdose if the user does not clear the moat area…
Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results
The recall described in this notice is due to the same issue that was announced in the September 17, 2021 Letter to Health Care Providers: Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. The FDA has identified this as a Class I recall, the most…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
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 have a quick update on another recent FDA cancer therapeutic approval. On October 1, 2021, the FDA approved brexucabtagene autoleucel (brand…
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity
Summary Company Announcement Date: October 14, 2021 FDA Publish Date: October 14, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description API batches above the specification limit for the impurity, N-nitrosoirbesartan Company Name: Lupin Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg…
UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers
October 13, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with stakeholders including public health partners, manufacturers, and experts to evaluate additional strategies to reduce the risk of infection from using these…
Eating Too Much Salt? Ways to Cut Back…Gradually
[embedded content] Español Did you know that “salt” and “sodium” are not the same thing, even though they’re often used interchangeably? Sodium, a mineral, is one of the elements found in salt. Salt is where most of your sodium comes from. The U.S. Food and Drug Administration is working to make sure people have greater…
Texas Pharmacist Pleads Guilty to Adulterating Drug Used in Cataract Surgeries
U.S. Department of Justice FOR IMMEDIATE RELEASEWednesday, October 13, 2021 A Texas man pleaded guilty Tuesday to one count of adulterating a drug that was used in cataract surgeries. According to court documents, Jack Randall Munn, 71, of Dallas, a licensed pharmacist and former owner of Guardian Pharmacy Services (Guardian), a Dallas pharmacy, oversaw the…