The Recall Desk
SevereFDA (Drugs)·D-763-2013·Announced 2013-07-17

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.

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 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
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.

See all 105 products in this recall →