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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Category
- Drug — Ophthalmic
- Hazard
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
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.
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