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.
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 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
- 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.
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