Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Nurse Assist Sterile Saline Placed Into the Following Kits; AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit

Summary Company Announcement Date: January 22, 2024 FDA Publish Date: January 23, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product cannot be verified as having the required sterility assurance level Company Name: Aligned Medical Solutions Brand Name: Brand Name(s) Aligned Medical Solutions Product Description: Product Description Convenience kits containing saline Company…

Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination

Summary Company Announcement Date: January 24, 2024 FDA Publish Date: January 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial Contamination Company Name: Haleon Brand Name: Brand Name(s) Robitussin Product Description: Product Description Cough syrups Company Announcement FOR IMMEDIATE RELEASE – January 24, 2024 – Warren, NJ, Haleon is voluntarily recalling eight…

Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing

Summary Company Announcement Date: January 24, 2024 FDA Publish Date: January 25, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled package Company Name: Azurity Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description dextroamphetamine sulfate tablets, 30 mg Company Announcement FOR IMMEDIATE RELEASE – January 24, 2024 – Woburn, Massachusetts, Azurity…

Today The World Issues Voluntary Nationwide Recall of All Lots of Arize Herbal Dietary Supplement Capsules Due to the Presence of Undeclared Nortadalafil

Summary Company Announcement Date: February 02, 2024 FDA Publish Date: February 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Products contain undeclared Nortadalafil Company Name: Today the World Brand Name: Brand Name(s) Product Description: Product Description Arize brand male enhancement capsules Company Announcement ‘The company has issued a correction to the previous…

Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil

Summary Company Announcement Date: February 02, 2024 FDA Publish Date: February 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Products contain undeclared Tadalafil and Nortadalafil Company Name: Today the World Brand Name: Brand Name(s) Sustain, Schwinnng Product Description: Product Description Sustain and Schwinnng brand male enhancement capsules Company Announcement FOR IMMEDIATE RELEASE…

Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune’s Fix

Summary Company Announcement Date: January 28, 2024 FDA Publish Date: January 29, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tianeptine Company Name: Neptune Resources, LLC Brand Name: Brand Name(s) Neptune’s Fix Product Description: Product Description Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets Company Announcement Neptune Resources,…

Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps – Letter to Health Care Providers

November 20, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the FDA further evaluates this issue.  In June 2023, Cardinal Health began distributing Monoject syringes branded as “Cardinal Health” Monoject syringes. These…

Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Due to the Presence of Benzene

Summary Company Announcement Date: February 01, 2024 FDA Publish Date: February 02, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company Name: Insight Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Company Announcement TARRYTOWN, N.Y.–(GLOBE NEWSWIRE)-February 1, 2024—Insight Pharmaceuticals, a Prestige…