Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: July 08, 2020 FDA Publish Date: July 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitrosodimethylamine (NDMA) Impurity Company Name: Lupin Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Company Announcement Lupin Pharmaceuticals Inc. is voluntarily recalling all batches…

Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System

Summary Company Announcement Date: June 15, 2020 FDA Publish Date: July 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Company Name: Endologix® Inc. Brand Name: Brand Name(s) Product Description: Product Description Ovation iX system…

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

Summary Company Announcement Date: July 03, 2020 FDA Publish Date: July 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Use of the pump system potentially could cause over-infusion or under-infusion of therapy Company Name: CME America Brand Name: Brand Name(s) Product Description: Product Description Infusion System Administration Set (infusion set) Company…

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

Summary Company Announcement Date: July 07, 2020 FDA Publish Date: July 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Mylan Institutional LLC Brand Name: Brand Name(s) Product Description: Product Description Daptomycin for Injection Company Announcement Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional…

ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential Presence of Undeclared Methanol (Wood Alcohol)

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…

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…