Agency classClass IIOur severity:Severe FDA (Drugs)·D-0194-2015·Announced 2014-11-12

FDA Recalls Sterile Glutaraldehyde Solution Due to Quality Control Concerns

Oregon Compounding Centers is recalling sterile glutaraldehyde solution for irrigation due to quality control issues affecting sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance risks for sterile products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle. The product is manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds, located in Wilsonville, Oregon. The recall covers all lots of sterile products compounded by the pharmacy that are not expired.

The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection. The specific lots identified in the recall notice include Lot # 20140722@5 with a discard date of 10/20/2014, and Lot # 20140723@45 with a discard date of 10/21/2014. The product was distributed in Oregon and Washington.

Healthcare providers and consumers should stop using the affected product and contact the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Sterile Irrigation Solution
Hazard: sterility-assurance
quality-control

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot #: 20140722@5
discard date: 10/20/2014
Lot #: 20140723@45
discard date: 10/21/2014.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 56 products in this recall →

Same manufacturer · Oregon Compounding Centers, Inc. dba Creative Compounds

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