US Compounding Recalls Prednisolone Eye Drops Due to Sterility Concerns
US Compounding Inc is recalling Prednisolone Sodium Phosphate eye drops due to deficient practices that may impact 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 assurance of sterility in a sterile preparation, which meets the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
US Compounding Inc is recalling Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottles intended for topical ophthalmic use. The recall is being conducted because of deficient practices that may have an impact on the assurance of sterility for the sterile preparations.
The affected product is compounded by US Compounding Pharmacy in Conway, Arkansas. The specific lot code is 20150209@16, and the beyond-use date is 10/2/2015. The distribution pattern for this recall is nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Affected units
- 1
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 (1)
- Lot Code: 20150209@16 BUD: 10/2/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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