PlainRecalls
FDA Drug Moderate Class II Terminated

GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070

Reported: November 12, 2014 Initiated: October 6, 2014 #D-0194-2015

Product Description

GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070

Reason for Recall

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.

Details

Units Affected
250 mL
Distribution
Oregon, Washington
Location
Wilsonville, OR

Frequently Asked Questions

What product was recalled?
GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070. Recalled by Oregon Compounding Centers, Inc. dba Creative Compounds. Units affected: 250 mL.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 12, 2014. Severity: Moderate. Recall number: D-0194-2015.