FDA Warning on Sterile Drugs From I.V. Specialty Ltd.

 By Walter F. Roche Jr.

The U.S. Food and Drug Administration (FDA) is advising patients and medical professionals to quarantine and not administer sterile drugs produced by an Austin, Tex. firm cited for repeat violations of sterility requirements.
The advisory was issued Wednesday for products prepared by I.V. Specialty Ltd., a company that had, but lost a license to mass produce compounded drugs under a new law aimed at ending drug compounding abuses.
FDA records show inspectors have cited the firm for multiple violations of sterility requirements.
According to the announcement, the FDA asked the Texas firm to cease the production of sterile drugs and to recall any unused products, but the company refused.
 "The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty," the FDA stated in the alert.
While the agency said that no adverse events have been reported, they advised patients and medical professionals to report any adverse reactions from the company products.
In an April 21, 2015 warning letter to the company the FDA warned that the company practices  placed patients at risk.

"During FDA’s inspection of your facility, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, the investigators observed your operators processing sterile drug products with exposed hair, ears, and forehead," the letter stated.

On its website the firm lists the following as its products for use in home infusion therapy:

Home Infusion Therapies

I.V. Specialty's team of experts specializes in the following home infusion therapies:

Antibiotics	Chemotherapy
TPN	Hydration
IVIG	Solumedrol/IV Steroids
Remicade	Dobutamine/Milrinone
Pain Management	Antiemetics

Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert - Lack of Sterility Assurance

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[Posted 03/09/2016]
AUDIENCE: Pharmacy, Nursing, Veterinary Medicine, Infectious Disease
ISSUE: The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile.  The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty.
BACKGROUND: During FDA’s recent inspection of I.V. Specialty, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about I.V. Specialty’s ability to assure the sterility of the drug products it produces.  Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
RECOMMENDATION: Health care professionals and consumers should immediately check their medical supplies, quarantine any drug products labeled as sterile from I.V. Specialty, and not administer them to patients.  Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/09/2016 - CDER Alert - FDA]

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Page Last Updated: 03/09/2016
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