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
FDA Updates on Valsartan RecallsWednesday, July 25, 2018
Investigation ongoing – statement to be updated as more information is available
FDA publishes a list of valsartan-containing products not part of the recall
Update [7/24/2018] FDA is updating health care professionals and consumers on the agency’s progress in responding to the ongoing recalls of valsartan, which is used to treat high blood pressure and heart failure, due to the presence of NDMA. The agency has posted a list of valsartan-containing products not impacted by this 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.
Manufacturers of these products often produce multiple dosage strengths, however not all of them are being recalled. FDA recommends health care professionals and patients carefully check these lists. Health care professionals and patients should check this statement frequently for any updates.
FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. Untreated heart failure increases the risk of hospitalization and death.
Consumers and health care professionals should continue to report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178
Update to FDA Announcement Re Voluntary Recall of Several Medicines Containing ValsartanThursday, July 19, 2018
This press release was updated on July 17, 2018, to add links to the press releases issued by each company, to include information about supplier of the active ingredient and to update the contact information for consumers.
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.Read More
Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion ReactionsMonday, July 16, 2018
Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.
Daptomycin for Injection has been associated with reports of adverse events indicative of infusion reactions, including chills, tremor, pyrexia and dyspnea. Other infusion reaction adverse events, that were reported, included events such as tachycardia and blood pressure changes. This recall decision is made out of an abundance of caution for patients while Hospira continues its investigation into the reported infusion reactions.Read More