SGLT2 Inhibitors for Diabetes: Rare Occurrences of a Serious Infection of the Genital AreaThursday, August 30, 2018
FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.Read More
Class 2 Device Recall AMIA Automated PD CyclerTuesday, August 21, 2018
Baxter Healthcare Corporation has issued a recall for the following power cords:
- AMIA Automated PD Cycler, Product Code: 5C9320
- Kaguya PD System, Product Code: T5C8500
Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen DeliveryFriday, August 10, 2018
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(s): AirLife Resuscitation Devices
- Product Codes: 2K8004, 2K8035C2, 2K8017, 2K8005, 2K8018, 2K8008, 2K8036, 2K8001, RE1DK5445D,2K8035M,2K8039,2K8004C2
- Manufacturing Dates: February 5, 2018 to February 28, 2018
- Distribution Dates: February 2, 2018 to April 20, 2018
- Devices Recalled in the U.S.: 15,714 units nationwide
FDA updates on valsartan recallsFriday, August 10, 2018
Investigation ongoing – statement to be updated as more information is available
FDA updates recalled valsartan-containing product information
Update [8/9/2018] FDA has updated the list of valsartan products under recall and the list of valsartan products notunder recall to incorporate recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc. Not all Camber valsartan products distributed in the U.S. are being recalled.
Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals.
Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang.
FDA is testing samples of valsartan API and finished products to confirm the extent and amount of NDMA and help inform the ongoing investigation. The agency has also contacted other manufacturers of valsartan API to determine if their manufacturing processes are at risk for the formation of NDMA, and is working with them to ensure NDMA is not present in future valsartan API.
Valsartan is an angiotensin II receptor blocker (ARB), and FDA is investigating whether other types of ARBs are at risk for the presence of NDMA.
Recalled valsartan products labeled as Camber may be repackaged by other companies. FDA will provide updates as more information becomes available.Read More
Hepatitis UpdatesFriday, August 10, 2018
The FDA recently approved revisions to the MAVYRET™ (glecaprevir and pibrentasvir) tablets label to include safety and efficacy data from the HCV/HIV-1 coinfection study (M14-730) and from the liver and renal transplant study (M13-596). A summary of the major revisions is provided.Read More
Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell TransplantFriday, August 3, 2018
The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. We are reviewing additional data and will communicate our conclusions and recommendations when our review is complete.Read More
FDA updates on valsartan recallsFriday, August 3, 2018
FDA updates recalled valsartan-containing product information and reminds API manufacturers to evaluate processes for unsafe impurities
Update [8/2/2018] FDA continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included in the recall. In addition to updating the lists, FDA revised information related to A-S Medication on the list of products included in the recall. The agency will continue to provide information when it becomes available.
FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities. If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product’s safety profile.Read More
AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vialWednesday, August 1, 2018
AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was found to contain silicone material. This problem was discovered as a result of two product complaints in which the contents of one vial from batch PP0317012-A was found to contain a glass particle and the contents of one vial from batch PP0317059A was found to contain a silicone particle.Read More
Update on Valsartan Recalls: FDA updates both lists of products included in the recall and the list of products NOT included in the recallMonday, July 30, 2018
Today, FDA is updating health care professionals and patients after discovering that several additional companies that repackage drug products are also recalling valsartan-containing products.
FDA has product recall information from three additional repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. – labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack – and the agency has added them to the recalled products list. Two of these companies, A-S Medication and RemedyRepack, may also distribute valsartan products not affected by the recall. The agency is confirming this information and will provide an update once it is available.
The following additional repackagers are recalling or are expected to recall valsartan-containing products. FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:
- Bryant Ranch Prepack Inc.
- H. J. Harkins Company Inc. (this company was not originally included on either list)
- Lake Erie Medical, doing business as Quality Care Products LLC
- NuCare Pharmaceuticals Inc.
- Northwind Pharmaceuticals
- Proficient Rx
It is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall. FDA continues to evaluate valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available.
UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety CommunicationWednesday, July 25, 2018
In January 2018, the FDA issued a Safety Communication alerting patients and health care providers that the LifeVest 4000 may fail to deliver a life-saving shock to a patient if the device is not replaced soon after displaying "Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102." Failure to contact Zoll immediately and replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death of the patient because the device may fail to deliver treatment if needed. Zoll issued a voluntary recall for the LifeVest 4000 on January 14, 2018 due to the potential for the device to not deliver treatment. Since January, Zoll has updated FDA with information on their plan to address the Message Code 102 issue as follows:
- Zoll Patient Service Representatives use the WEAR Checklist during patient fitting and training to reinforce instructions about how to wear the device, when to change the battery, and how to respond to siren alerts and gong alerts. Patients sign the WEAR Checklist and the checklist is returned to Zoll to be kept on file. Zoll updated the WEAR Checklist to include these instructions: “Call Zoll immediately if “Call for Service – Message Code 102” appears on the LifeVest screen. A replacement device will be provided within 24 hours.” The updated WEAR Checklist has been provided with each new LifeVest system shipment since March 21, 2018 as Zoll’s form of patient communication for the recall.
- Zoll is planning to implement a software design change for the LifeVest 4000 with a new, more prominent and persistent message scheme for Code 102. The proposed software change needs to be submitted to FDA for review and approval.
The FDA believes that the updated WEAR Checklist for patients with instructions about how to respond to Message Code 102 will help increase awareness of the potential hazard and increase the likelihood of a patient contacting Zoll immediately for a replacement device after the alert appears on the device screen. The FDA will work expeditiously to review any changes from Zoll that may affect patient safety and will continue to work with Zoll to identify a permanent solution to the Message Code 102 issue.Read More