The Recall Desk
SevereFDA (Drugs)·D-794-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Voriconazole 5% Ophthalmic Drops Due to Sterility Concerns

Olympia Pharmacy is recalling Voriconazole 5% Ophthalmic drops because FDA inspections raised concerns about quality control and 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility concerns for ophthalmic products which carry significant risk of injury.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one lot of Voriconazole 5% Ophthalmic drops. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is A5615 with an expiration date of 6/6/13.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product. The agency classified this recall as Class II.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Voriconazole 5% Ophthalmic drop 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)

  • A5615 Exp 6/6/13

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 →

Related recalls

Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy

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Same hazard · sterility concern

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