FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

Summary Company Announcement Date: January 15, 2020 FDA Publish Date: January 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of Assurance of Sterility Company Name: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutcal Brand Name: Brand Name(s) AXIA Pharmaceutical Product Description: Product Description Sterile Drug Products Company Announcement FUSION IV Pharmaceuticals, Inc…

Surgical Gowns and Packs by Cardinal Health: FDA Statement – Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

[Posted 01/16/2020] AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.  FDA also understands this issue may already be impacting patient care at health care facilities, such as the cancellation of…

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year in the U.S. These devices have complex designs that include reusable hard-to-clean components. Failure to correctly reprocess a duodenoscope could result…

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited

Summary Company Announcement Date: January 08, 2020 FDA Publish Date: January 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Mylan N.V. Brand Name: Brand Name(s) Product Description: Product Description Nizatidine Capsules 150mg and 300mg Company Announcement Mylan N.V.(NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals…

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

Summary Company Announcement Date: January 10, 2020 FDA Publish Date: January 10, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Cross contamination with another drug substance, Enalapril Maleate Company Name: Taro Pharmaceuticals U.S.A., Inc. Brand Name: Brand Name(s) Taro Pharmaceuticals Product Description: Product Description Lamotrigine Tablets, USP 100mg Company Announcement Taro Pharmaceuticals U.S.A.,…

Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator

Summary Company Announcement Date: December 27, 2019 FDA Publish Date: January 10, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Failure to deliver a defibrillation shock after the “Shock” button on the keypad is pressed Company Name: Stryker Brand Name: Brand Name(s) LIFEPAK 15 Product Description: Product Description LIFEPAK 15 monitor/defibrillators Company…

Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination

Summary Company Announcement Date: December 23, 2019 FDA Publish Date: January 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Burkholderia cepacia Company Name: Mavidon Brand Name: Brand Name(s) LemonPrep®, PediaPrep®, Wave Prep, Cardio Prep Product Description: Product Description LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep…

Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: January 06, 2020 FDA Publish Date: January 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Denton Pharma, Inc. dba Northwind Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description Ranitidine Tablets 150mg and 300mg Company Announcement Denton Pharma, Inc. dba Northwind Pharmaceuticals, an…

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: January 07, 2020 FDA Publish Date: January 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Appco Pharma LLC Brand Name: Brand Name(s) Product Description: Product Description Ranitidine Tablets 150mg and 300mg Company Announcement Appco Pharma LLC (Appco) is voluntarily recalling all quantities and…