Summary Company Announcement Date: March 24, 2022 FDA Publish Date: March 24, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial Contamination Company Name: Plastikon Healthcare, LLC Brand Name: Brand Name(s) Major Pharmaceuticals Product Description: Product Description Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and…
Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity
Summary Company Announcement Date: March 21, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a Nitrosamine Impurity Company Name: Sandoz, Inc. Brand Name: Brand Name(s) Product Description: Product Description Orphenadrine Citrate 100 mg Extended Release (ER) Tablets Company Announcement Princeton, NJ, Sandoz Inc. (“Sandoz”) is…
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only
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 Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test (labeled for Research Use Only) Product Code: 83QKP Lot Numbers: See Recall Database Entry Devices Recalled in the U.S.:…
Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life
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 Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See Recall Database Entry Distribution Dates: June 2, 2021, to December 21, 2021 Devices…
Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm
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 Product Name: Philips Respironics V60 and V60 Plus Ventilator Product Codes and Serial Numbers: See recall database entries: Distribution Dates: July 29, 2021 to August 11, 2021…
FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
Date Issued: March 14, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures. Specifically, the FDA is warning against the use for procedures intended to improve the appearance of the skin through dermal resurfacing (a…
Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication
Date Issued: March 18, 2022 The U.S. Food and Drug Administration (FDA) is alerting people that there is a potential for harm if FDA authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. The FDA is also reminding people to keep the tests out of reach from children and pets. …
Celltrion USA Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life
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 Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See Recall Database Entry Distribution Dates: June 2, 2021, to December 21, 2021 Devices…
SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
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 Product Name: SD Biosensor STANDARD Q COVID-19 Ag Home Test Product Codes and Lot Numbers: See recall database entry Distribution Dates: August 26, 2021 to January 30,…
Celltrion USA Recalls Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life
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 Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See Recall Database Entry Distribution Dates: June 2, 2021, to December 21, 2021 Devices…