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Need To Know

Need to Know Need to Know

This month's "Need to Know"...

"In Previous Need to Know News"...

  • KCER Watch FDA MedWatch: Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication
  • KCER Watch FDA MedWatch:Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips
  • KCER Watch FDA MedWatch:Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets
  • KCER Watch FDA MedWatch: Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide
  • KCER Watch FDA MedWatch: SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area
  • KCER Watch FDA MedWatch: Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up.
  • KCER Watch FDA MedWatch: Hepatitis Updates
  • KCER Watch FDA MedWatch: AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial
  • KCER Watch "FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity"
  • KCER Watch "Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions"
  • KCER Watch "Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects"
  • KCER Watch Safety and Health Topics: Emergency Preparedness Bulletin May 2018
  • KCER Watch-Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter
  • KCER Watch- Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter
  • KCER Watch Safety and Health Topics: Emergency Preparedness Bulletin- The Federal Emergency Management Agency Invites Whole Community to Participate in National Level Exercise- April 2018

Special Alerts & Recalls

New Medicare Card Project Special Open Door Forum — Tuesday, January 23rd from 2 PM to 3 PM ET

This call will educate State Medicaid Agencies, Medicaid providers, Managed Care Organizations, Medicaid partners, and other Medicaid stakeholders about the change from Social Security Number-based Health Insurance Claim Numbers to new Medicare Beneficiary Identifiers (MBIs). A question and answer session follows the presentation. This is the same presentation given on November 9.

CMS discusses:

  • Background and implementation
  • MBI format
  • Timeline and milestones, including the transition period
  • Beneficiary outreach and education
  • How to get ready for the new number

Dial in at least 15 minutes prior to the start of the call.

  • Dial-In Number: 800-837-1935; conference ID #: 8259057
  • TTY services dial 7-1-1 or 800-855-2880

For More Information

Provider Ombudsman, Dr. Eugene Freund: NMCProviderQuestions@cms.hhs.gov 


Low Volume Appeals Initiative- National Provider Call (NPC): CMS will host a Medicare Learning Network event on Tuesday January 9, 2018 from 1:30 to 2:30pm. This NPC will cover the logistics of this settlement process.  Please submit your questions in advance to MedicareSettlementFAQs@cms.hhs.gov and include “Low Volume Appeal Settlement Process January NPC” in the subject line.  Questions received in advance may be addressed during the call or referenced in materials following the call. Registration details will be available here: https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events.html.

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls - November 2017 Update on the efforts by the FDA to address IV fluid shortages exacerbated by Hurricane Maria and advice for hospitals in managing the shortage

Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter - September 2017 Hospira is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - August 2017 Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.

Pravastatin Sodium Tablets by International Laboratories: Recall – Mislabeling - August 2017 International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A

Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use - August 2017 FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection. Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on August 3, 2017, of two such products – Diocto Liquid and Diocto Syrup, both oral liquid docusate products – manufactured by PharmaTech.

Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks -  July 2017 Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar.

Clindamycin Injection ADD-Vantage Vials by Alvogen Recall - Lack of Sterility Assurance - June 2017 Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.

Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly - March 2017

Chlorhexidine Gluconate: Drug Safety Communication – Rare but Serious Allergic Reactions - February 2017 FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years.

Recall for Over 205,000 Fresenius 2008 Dialysis Machines due to UF Rate Errors - January 2017 When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine.

Tego Connector Recall - January 2017 The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego is a needle-free capping device which closes the end of the catheter. The Tego will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.