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Alerts and Recalls

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  • 0.9% Sodium Chloride Injection by ICU Medical: Recall

    Monday, July 31, 2017
    ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. Injection of particulate matter could...

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  • Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

    Friday, July 28, 2017
    Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been...

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  • Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

    Wednesday, July 26, 2017
    Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and...

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  • Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks

    Thursday, July 6, 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. NovoPen Echo® is used for insulin treatment by people with diabetes. 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. Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low.

    For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click here.

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  • FDA Med Watch: Clindamycin Injection ADD - Vantage Vials by Alvogen - Recall: Lack of Sterility Assurance

    Monday, June 19, 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.

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  • CMS Memo: REVISED ESRD Facilities - Filling Saline Syringes at the Patient Treatment Station

    Tuesday, June 6, 2017

    The 2008 ESRD Conditions for Coverage at 42 CFR 494.30(b)(2) state that the facility must "ensure that the clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications…"

    Dialysis procedures for initiation and discontinuation of hemodialysis treatments require the use of sterile normal saline in syringes to aid in the care of a patient’s vascular access. During survey observations, ESRD facilities have been noted to fill syringes with saline for vascular access care or to flush medications by drawing saline from the single dose saline bag or the IV tubing connected to the patient at the dialysis station.

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  • CMS Memo: ESRD Facilities - Cleaning the Patient Station

    Tuesday, June 6, 2017

    Dialysis facilities are traditionally configured with individual treatment bays, called dialysis "stations," where patients receive their in-center dialysis treatments. Dialysis stations contain a patient chair or bed and the dialysis delivery equipment. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses.

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  • New CDC Report: Spread of Resistant Fungus, C. auris

    Thursday, May 25, 2017

    CDC has just released an MMWR update on Candida auris (C. auris) cases identified in U.S. health care facilities through May 2017. In June 2016, CDC released the first clinical alert about C. auris. Soon after, CDC began reporting on the first U.S. cases. Although C. auris is still rare in the United States, we are seeing an increasing number of cases. The MMWR provides information on the 77 C. auris cases reported to CDC through May 12, 2017.

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  • 2017 Large Scale Cyber Attack: Update

    Wednesday, May 17, 2017

    CMS EPRO, along with CMS cyber security personnel, continues to support the HHS Emergency Management Group and the collective response to the 2017 Large-Scale Cyber Attack, we wanted to provide you an update as of 8:45 AM EDT, Monday May 15, 2017.

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  • FDA MedWatch: Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations

    Tuesday, May 16, 2017

    Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

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