Olympia Pharmacy Recalls Phenylbutazone Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Phenylbutazone 200 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility concerns) where no specific injuries or illnesses have been reported in the source text, aligning with the 'High' severity criteria.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Phenylbutazone 200 mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, FL, and distributed nationwide and to Puerto Rico. The specific product code is A5224 with an expiration date of 8/1/13.
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 has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Phenylbutazone 200 mg/ml 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)
- A5224 Exp 8/1/13
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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