We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Compounding Pharmacy Relents to FDA’s Recall Request

Compounding Pharmacy Relents to FDA’s Recall Request

August 8, 2014

After initially rejecting FDA’s authority over its operations, a Texas compounding pharmacy acceded to the agency’s request to cease production and recall all of its sterile products due to quality concerns.

Unique Pharmaceuticals voluntarily recalled all of its sterile products on July 19 after a series of FDA inspections questioned the sterility assurance of its products. In its recall, Unique says it hasn’t received any reports of adverse events associated with its sterile compounds, and there is no evidence of contamination in any of the released sterile products.

During a March-to-April inspection of the company’s Temple, Texas, facility, FDA investigators cited numerous violations, including that the company didn’t conduct tests on preservatives used in 16 sterile products at the time of their release, according to a Form 483 issued April 4. The products include lorazepam, dexamethasone and labetalol.

The FDA also chided Unique for not requiring technicians to fully cover their face when working in aseptic processing areas.

During a follow-up June inspection, the FDA cited Unique for poor investigations into sterility failures. Between January and March, the company produced batches of drug products that failed sterility tests, and a batch of neostigmine that failed endotoxin tests, according to the Form 483 issued June 20. The firm “did not document or identify any preventative actions that address lab methods or possible environmental contaminants as a root cause for the failures,” it added.

On July 11, the FDA posted a safety alert warning healthcare professionals to stay away from Unique’s sterile products. The agency also asked the Texas facility to recall its products and cease operations.

But Unique rebuffed that request, noting in a July 14 press release that it did not distribute any sterile drugs that failed sterility tests. Furthermore, there was no evidence that any of the preparations in question failed to meet performance specifications, the company added.

Unique also warned that any recall could affect supplies and potentially lead to drug shortages.

The compounder continues to believe that the products being recalled are safe and sterile. However, it went forward with the recall out of an abundance of caution, spokesman David Shank said.

Unique, which has hired third-party experts to address the concerns, also is temporarily suspending distribution of sterile products to address the FDA’s concerns about alleged sterility issues at the facility. Unique continues to produce non-sterile preparations, Shank said.

The company has voluntarily registered with the FDA under a new regulatory category that means the compounder is subject to agency inspections and must meet its own set of good manufacturing practices.

Don’t be forced to cease production and implement costly recalls. Avoid manufacturing mistakes by purchasing Focus on GxPs: A DVD Training Toolkit for Your Most Common and Costly Manufacturing Mistakes.

Pharmaceuticals Quality Regulatory Affairs Postmarket Safety

Upcoming Events

  • 19Jan

    Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management

  • 21Jan

    Virtual MDSAP Audits in the Era of COVID-19: What to Know and Do to Pass Virtual Audits

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Regeneron logo

    U.S. Government Orders More Supplies of Regeneron’s COVID-19 Antibody Cocktail

  • Siemens Healthineers logo

    Siemens Healthineers COVID Test Gets Additional Sampling Method Clearance

  • COVID-19  Clinical Trial

    Synairgen Initiates Dosing in Late-Stage Trial of Inhaled COVID-19 Therapy

  • Verona Pharma logo

    Verona Pharma Ends Enrollment in Inhaler-Administered COVID-19 Drug Pilot

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing