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 two recent FDA cancer drug approvals. On October 12, 2021, the FDA approved abemaciclib (brand name…
Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect Strength
Summary Company Announcement Date: October 18, 2021 FDA Publish Date: October 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Bottles labeled as Methocarbamol 500mg tablets were found to contain Methocarbamol 750mg tablets. Company Name: Bryant Ranch Prepack Brand Name: Brand Name(s) Bryant Ranch Prepack Product Description: Product Description Methocarbamol 500mg Company Announcement…
Pregnant? Breastfeeding? Better Drug Information Is Coming
Image Español Women and their health care providers can look forward to getting more useful and up-to-date information over the next few years about the effects of medicines during pregnancy and breastfeeding. The improvements will replace the current, decades-old labeling system and implement new requirements by FDA regarding labeling information for prescription drugs and biological…
Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles
Summary Company Announcement Date: October 19, 2021 FDA Publish Date: October 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains particulate matter identified as glass Company Name: Merck Brand Name: Brand Name(s) Product Description: Product Description Daptomycin for injection 500mg Company Announcement KENILWORTH, N.J., Oct. 19, 2021 – Merck (NYSE: MRK),…
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…