The Recall Desk
SevereFDA (Drugs)·D-742-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Idoxuridine Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Idoxuridine 0.1% Injection 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 with potential for serious health consequences (such as sterility issues in injectable drugs) are rated as Severe (4), especially when not explicitly ruled out as low-risk.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Idoxuridine 0.1% Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot affected is L5703, with an expiration date of 11/30/2013.

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 has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. No specific illnesses or injuries are reported in the source text.

The recalled product

Product
Idoxuridine 0.1% Injection, 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)

  • L5703 Exp 11/30/2013

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 →