Reported Nov 12, 2014 · Terminated

GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds,…

Oregon Compounding Centers, Inc. dba Creative Compounds

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Oregon Compounding Centers, Inc. dba Creative Compounds · 8560 Sw Salish Ln Ste 100 · Wilsonville, OR · 97070-9625

Is this the product you have?

  • GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070
Lot codes and dates
  • Lot #: 20140722@5
  • discard date
    • 10/20/2014
    • Lot #: 20140723@45
  • discard date10/21/2014
Amount recalled
250 mL

This recall covers 56 products

The agency filed one notice per product. You are reading one of them; the other 55 are below.

43 more are in the archive.

Where it was sold

Why it was recalled

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 30, 2015 · Data as of Sep 19, 6:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.