FDA Recalls Compounded Dexamethasone Eye Ointment Over Sterility Concerns
Olympia Pharmacy is recalling one unit of compounded BNP/dexamethasone eye ointment because FDA inspection findings raised concerns about sterility assurance and quality control. The listed distribution is nationwide and Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified by FDA as Class II, but the source does not report hospitalizations, so the rubric's Severe criterion is not met. The source contains no report of injury, and the sterility-assurance concern is a risk-of-harm issue, supporting a High rating under the rubric's risk-of-harm criterion.
Plain-English summary
The FDA is recalling one unit of BNP/dexamethasone eye ointment compounded by Lowlite Investments, Inc. d/b/a Olympia Pharmacy in Orlando, Florida. The listed code is B5119, with expiration date 10/31/13.
FDA inspection findings raised concerns about the product's quality-control processes and created a lack of assurance that the ointment was sterile.
The recall lists distribution as nationwide and Puerto Rico. The provided source text does not state what consumers should do.
The recalled product
- Product
- BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Compounded Eye Ointment
- Hazard
- 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)
- B5119 exp 10/31/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy 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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