Olympia Pharmacy Recalls Neomycin Polymyxin Dexamethasone Ophthalmic Drops
Olympia Pharmacy is recalling compounded ophthalmic drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 compounded ophthalmic product, which poses a significant risk of serious injury or infection.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Neomycin / Polymyxin / Dexamethasone Ophthalmic Drops. The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and a lack of assurance of sterility.
The affected product is identified by code A5531 with an expiration date of 6/5/13. The product was distributed nationwide and in Puerto Rico.
Consumers should stop using the recalled ophthalmic drops and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Neomycin / Polymyxin / Dexamethasone Ophthalmic Drops, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Ophthalmic
- 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)
- A5531 Exp 6/5/13
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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