Summary Company Announcement Date: July 06, 2020 FDA Publish Date: July 06, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol (wood alcohol). Company Name: ITECH 361 Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand…
Arrow International Inc. Recalls Arrow AutoCAT®2 and AC3 Optimus® IABP Series Due to Possible Breakdown of Motor Connector Wires
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Arrow AutoCAT®2 and AC3 Optimus® Intra-Aortic Balloon Pump Series Model, Product Names, Product Codes, and Serial Numbers: See List of Affected Devices Manufacturing Dates: 08/01/2014 to 01/2020…
Transliquid Technologies LLC Issues Voluntary Recall of Mystic Shield Protection Topical Solution Due to Presence of Undeclared Methanol for the States of California, Louisiana, Massachusetts, and Texas
Summary Company Announcement Date: July 02, 2020 FDA Publish Date: July 02, 2020 Product Type: CosmeticsDrugs Skin Care Products Reason for Announcement: Recall Reason Description Undeclared methanol Company Name: Transliquid Technologies LLC Brand Name: Brand Name(s) Mystic Shield Product Description: Product Description Mystic Shield Protection Topical Solution Company Announcement Transliquid Technologies LLC is voluntarily recalling…
UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
Summary Company Announcement Date: June 29, 2020 FDA Publish Date: June 29, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol (wood alcohol) Company Name: UVT, INC. Brand Name: Brand Name(s) Product Description: Product Description Advanced Hand Sanitizer, 70% alcohol content Company Announcement UVT, INC. is voluntarily recalling 38,830 liters…
Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produced by Eskbiochem SA de CV Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
Summary Company Announcement Date: June 26, 2020 FDA Publish Date: June 27, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description May contain methanol (wood alcohol) Company Name: Saniderm Products Brand Name: Brand Name(s) Product Description: Product Description Advanced Hand Sanitizer Company Announcement Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged…
Chengdu Ai Qin E-Commerce Co., Ltd Issues Nationwide Recall of TTDEYE Brand Colored Contact Lenses
Summary Company Announcement Date: June 24, 2020 FDA Publish Date: June 24, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Distributed without FDA clearance may pose health risk Company Name: Chengdu Ai Qin E-commerce Co., Ltd Brand Name: Brand Name(s) Product Description: Product Description Colored contact lenses Company Announcement On June 18, 2020,…
GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings
Summary Company Announcement Date: June 18, 2020 FDA Publish Date: June 18, 2020 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Incorrect dosing cups Company Name: GSK Consumer Healthcare Brand Name: Brand Name(s) Robitussin Product Description: Product Description Cough and cold products Company Announcement GSK Consumer Healthcare is voluntarily recalling to the…
Certain COVID-19 Serology/Antibody Tests Should Not Be Used – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage. The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or…
Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment
[Posted 06/15/2020] AUDIENCE: Health Professional, Pharmacy, Patient ISSUE: FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but, is…
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: June 11, 2020 FDA Publish Date: June 11, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Detection of N-Nitrosodimethylamine (NDMA) Company Name: Lupin Pharmaceuticals, Inc Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-release Tablets Company Announcement Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets…