The Recall Desk
SevereFDA (Drugs)·D-761-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Miconazole Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Miconazole 3% Injection because FDA inspection findings 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 source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. Since this is a Class II recall involving a sterile injection with sterility concerns, it falls under the 'Severe' category (Score 4) as it represents a significant risk of harm, even without explicit reports of hospitalization in the provided text snippet.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Miconazole 3% Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is B5001 with an expiration date of 6/1/13.

The recall was initiated due to 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 and healthcare providers should stop using the recalled Miconazole 3% Injection and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Injectable
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)

  • B5001 Exp 6/1/13

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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