Summary Company Announcement Date: September 23, 2020 FDA Publish Date: September 23, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Company Name: Sun Pharmaceutical Industries Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride for Extended-Release Oral Suspension Company Announcement Sun Pharmaceutical Industries, Inc….
BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Error
Summary Company Announcement Date: September 21, 2020 FDA Publish Date: September 21, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for four hardware situations that may result in the infusion pump not operating as expected Company Name: Becton, Dickinson and Company Brand Name: Brand Name(s) Product Description: Product Description BD Alaris…
Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency
Summary Company Announcement Date: September 17, 2020 FDA Publish Date: September 17, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Sub Potency Company Name: Acella Pharmaceuticals, LLC Brand Name: Brand Name(s) NP Thyroid 15 & NP Thyroid120 Product Description: Product Description Thyroid Tablets Company Announcement Acella Pharmaceuticals, LLC is voluntarily recalling one lot…
Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™ Syringe and Alaris™ PCA Modules Due to Potential Incorrect Display of Syringe Types and/or Sizes
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 BD Alaris™ Syringe Module; and BD Alaris™ PCA Module, Syringe/PCA Sizer Sensor Replacement Kit Model Number: BD Alaris™ Syringe Module Model 8110 BD Alaris™ PCA Module Model…
Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame
The FDA has identified the occurrence of Situation 1, 2 and 3 as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The FDA has identified the occurrence of Situation 4 as a Class II recall and use of these devices may cause temporary…
Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys
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 BD Alaris™ PC Unit Model 8015, PC Unit Front Case with Keypad Replacement Kits Affected Models: BD Alaris PC Unit 8015 Affected Keypads Replacement Kits: TC10008389 ASSY…
Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels
Summary Company Announcement Date: September 09, 2020 FDA Publish Date: September 10, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Methanol and may be Sub-Potent for Ethanol Company Name: Medek, LLC Brand Name: Brand Name(s) Product Description: Product Description M Hand Sanitizer Alcohol Antiseptic 80% Company Announcement Medek, LLC is voluntarily recalling…
FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication
Date Issued: September 9, 2020 The FDA monitors reports of adverse events and other problems with medical devices and alerts the public when needed to ensure proper use of devices and protect the health and safety of patients and users. The FDA is issuing this safety communication to inform patients and health care providers about…
Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up
Summary Company Announcement Date: August 28, 2020 FDA Publish Date: August 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Vials potentially packaged in incorrect cartons Company Name: Mylan N.V. Brand Name: Brand Name(s) Product Description: Product Description Tranexamic Acid and Amiodarone HCl injections Company Announcement Mylan N.V. (NASDAQ: MYL) today announced that…
AJR Trading LLC Issues Voluntary Nationwide Recall of bio aaa Advance Hand Sanitizer 480 mL Bottles, Lot 20DF8307
Summary Company Announcement Date: September 03, 2020 FDA Publish Date: September 03, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Possible presence of methanol Company Name: AJR Trading LLC Brand Name: Brand Name(s) Product Description: Product Description Hand Sanitizer Company Announcement AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio…