Recalls for Health Care Provider

Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
10/21/2015 Medical Recall

If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

  • Category
    Health Care Provider
Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance
09/24/2015 Medical Recall

If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.

  • Company:
    US Compounding, Inc.
Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance
07/25/2015 Medical Recall

If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

  • Category
    Health Care Provider
Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality
07/01/2015 Medical Recall

Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.

  • Category
    Health Care Provider
HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall
06/22/2015 Medical Recall

FDA will update recall with new information as it becomes available.

  • Company:
    HVAD
HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop
06/16/2015 Medical Recall

An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.

  • Company:
    HeartWare
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury
05/28/2015 Medical Recall

Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.

  • Category
    Health Care Provider
Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug
03/23/2015 Medical Recall

FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.

  • Company:
    Zyprexa Relprevv
Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries
01/21/2015 Medical Recall

Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling.

  • Category
    Health Care Provider
Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected
01/14/2015 Medical Recall

Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.

  • Company:
    Wallcur
L-citrulline by Medisca: Alert - Potentially Subpotent Product
02/14/2014 Medical Recall

Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.

  • Company:
    Medisca Inc
Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination
02/07/2014 Medical Recall

FDA testing confirmed the presence of gram-positive rod bacteria in the product, which can cause infection in patients.

  • Company:
    Rx Formulations
Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance
12/19/2013 Medical Recall

Use of Microbial contamination in products intended to be sterile can put patients at risk for serious, potentially life-threatening infections.

  • Category
    Health Care Provider
Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance
11/16/2013 Medical Recall

In the event a sterile product is compromised, patients are at risk for very serious infections.

  • Category
    Health Care Provider
Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials
10/21/2013 Medical Recall

If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Posted 10/21/2013

  • Category
    Health Care Provider
Inclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins
10/11/2013 Medical Recall

Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.

  • Company:
    Iclusig
Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor
09/09/2013 Medical Recall

If microbial contamination occurs in medications intended to be sterile, patients are at risk of serious infections that may be life threatening.

  • Company:
    Avella Specialty Pharmacy
JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor
08/27/2013 Medical Recall

If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

  • Company:
    JCB Laboratories