Olympia Pharmacy Recalls Diclazuril Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Diclazuril 10 mg/ml Injection because FDA inspections 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 identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), particularly given the risk of sterility failure in an injectable drug.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling Diclazuril 10 mg/ml Injection. The product was distributed nationwide and in Puerto Rico. The specific lot affected is identified by code B5014 with an expiration date of 8/14/13.
The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the product. The agency has classified this recall as Class II.
Consumers and veterinary professionals who possess this product should stop using it and contact Olympia Pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Veterinary 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)
- B5014 Exp 8/14/13
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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