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FDA MedWatch Alerts

Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

Parsippany, NJ. May 23, 2022 -- Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot...

FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

May 04, 2022 -- Today, the U.S. Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8...

Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination

April 29, 2022 -- St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy...

Bosentan REMS Requirements will Change June 27, 2022

On April 29, 2022, the U.S. Food and Drug Administration approved a modification to the Bosentan Risk Evaluation and Mitigation Strategy (REMS) program...

FDA Alerts Customers to Voluntary Recall of Compounded Drugs Due to Sterility Issues by Drug Depot, LLC, dba APS Pharmacy

April 26, 2022 --FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC...

Pfizer Voluntary Nationwide Recall of Lots of Accupril (Quinapril HCl) Due to N-Nitroso-Quinapril Content

NEW YORK, NY., April 22,2022 - Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient...

FDA Warns Consumers Not to Purchase or Use Artri and Ortiga Products, Which May Contain Hidden Drug Ingredients

April 20, 2021 --FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due...

FDA Works to Protect Consumers from Potentially Harmful OTC Skin Lightening Products

April 19, 2022 -- FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing hydroquinone that do not...

Mylan Issues Voluntary Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label

April 12, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn)...

FDA Warns Patients and Health Care Professionals Not to Use Sterile Products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding

March 30, 2022 -- FDA is warning patients and health care professionals not to use products intended to be sterile produced by North American Custom...

Drug Safety Communication - FDA Recommends Thyroid Monitoring in Babies and Young Children Who Receive Injections of Iodine-Containing Contrast Media for Medical Imaging

ISSUE: The FDA approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring...

Teva Issues Voluntary Nationwide Recall of One Lot of Idarubicin Hydrochloride Injection USP 5 mg/5 mL Due to the Presence of Particulate Matter

March 29, 2022 -- Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial...

Plastikon Healthcare Issues Voluntary Nationwide Recall of Certain Products Due to Microbial Contamination

March 24, 2022 - Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot...

Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of Symjepi (Epinephrine) Injection for Potential Manufacturing Defect

San Diego, March 21, 2022 – Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is voluntarily recalling certain lots of Symjepi (epinephrine) Injection...

Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity

March 22, 2022 -- Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100...

Letter to Health Care Personnel - Prefilled Saline Flush Syringe Conservation Strategies

March 21, 2022 -- The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing interruptions in the supply of prefilled 0.9% sodium...

Pfizer Voluntary Nationwide Recall of Lots of Accuretic, Quinapril and Hydrochlorothiazide, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-NitrosoQuinapril Content

NEW YORK, NY., March 21,2022. Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two...

Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification

March 10, 2022 -- Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and...

Fresenius Kabi Issues Voluntary Recall of Sodium Acetate Injection, USP Due to the Presence of Particulate Matter

LAKE ZURICH, Ill., March 7, 2022 – Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL)...

Tennessee Technical Coatings Corp. Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol

March 07, 2022 -- Tennessee Technical Coatings Corp. is voluntarily recalling all lots of HAND SANITIZER Isopropyl Alcohol Antiseptic 75% to the consumer/user...

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