Summary Company Announcement Date: December 09, 2020 FDA Publish Date: December 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to dissolution test failure Company Name: Torrent Pharmaceuticals Limited Brand Name: Brand Name(s) Torrent Pharmaceuticals Limited Product Description: Product Description Anagrelide Capsule USP 1mg Company Announcement Torrent Pharmaceuticals Limited is voluntarily recalling…
AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up
Summary Company Announcement Date: December 09, 2020 FDA Publish Date: December 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to product mix-up Company Name: AvKare Brand Name: Brand Name(s) Product Description: Product Description Sildenafil 100 mg tablets and Trazodone 100mg tablets Company Announcement AvKARE, Pulaski, TN is voluntarily recalling one lot…
Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication
Date Issued: December 7, 2020 The U.S. Food and Drug Administration (FDA) is informing patients and health care providers that patients may be injured if they wear face masks (such as surgical or non-surgical masks and respirators) with metal parts and coatings during a Magnetic Resonance Imaging (MRI) exam. Metal parts, like nose pieces sometimes…
WishGarden Herbs Issues Voluntary Nationwide Recall of Cord Care and Goldenseal Powder Due to Bacterial Contamination
Summary Company Announcement Date: December 04, 2020 FDA Publish Date: December 04, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product may be contaminated with Cronobacter sakazakii Company Name: WishGarden Herbs, Inc. Brand Name: Brand Name(s) WishGarden Herbal Remedies Product Description: Product Description Cord Care and Goldenseal Powder Company Announcement WishGarden Herbs, Inc….
UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication
Date: December 4, 2020 The U.S. Food and Drug Administration (FDA) is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2) to provide new data, review current recommendations, and announce the FDA’s intention to convene an Advisory Committee meeting in 2021. The…
WishGarden Herbs Issues Voluntary National Recall of 46 Units of Happy Ducts Compress Due to Bacterial Contamination
Summary Company Announcement Date: December 01, 2020 FDA Publish Date: December 01, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product may be contaminated with Cronobacter sakazakii. Company Name: WishGarden Herbs Brand Name: Brand Name(s) WishGarden Herbal Remedies Product Description: Product Description Happy Ducts Compress Company Announcement WishGarden Herbs, Inc. is voluntarily recalling…
MPM Medical LLC Issues Voluntary Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepecia Contamination
Summary Company Announcement Date: December 02, 2020 FDA Publish Date: December 02, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Burkholderia cepecia contamination. Company Name: MPM Medical, LLC Brand Name: Brand Name(s) MPM Medical Product Description: Product Description Regenecare HA Topical Anesthetic Hydrogel Company Announcement Mesquite, TX MPM Medical is voluntarily recalling one…
Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues
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 Products Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Product Code: 35700ABB and 35700BAX Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)…
Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements
Summary Company Announcement Date: November 22, 2020 FDA Publish Date: November 23, 2020 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Unapproved new drug Company Name: Fusion Health and Vitality LLC Brand Name: Brand Name(s) CORE, Immune Boost Product Description: Product Description CORE essential nutrients and Immune Boost Sublingual Vitamin D3 Company Announcement…
Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine
Summary Company Announcement Date: November 19, 2020 FDA Publish Date: November 19, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Cross Contamination with Lidocaine Company Name: Fresenius Kabi USA Brand Name: Brand Name(s) Fresenius Kabi USA Product Description: Product Description Dexmedetomidine HCL in 0.9% Sodium Chloride Injection Company Announcement Fresenius Kabi USA is…