Agency classClass IIOur severity:Severe FDA (Drugs)·D-0219-2015·Announced 2014-11-12

FDA Recalls Prednisolone Sodium Phosphate Eye Drops for Sterility Concerns

Oregon Compounding Centers is recalling Prednisolone Sodium Phosphate ophthalmic drops 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, and the hazard involves a lack of sterility assurance in a sterile product, which poses a significant risk of infection or injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Prednisolone Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottles. The product was compounded by Oregon Compounding Centers, Inc. dba Creative Compounds, located in Wilsonville, Oregon.

The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility of the products. This applies to all lots of sterile products compounded by the pharmacy that have not expired.

The affected product is distributed in Oregon and Washington. Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product: PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Ophthalmic
Hazard: sterility-failure

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 (2)

Lot #: 20140902@22
discard date: 10/17/2014

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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