Lipotoxin Injection Recalled Due to Sterility Concerns
Olympia Pharmacy is recalling Lipotoxin 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, which corresponds to the 'Severe' severity level in the rubric, particularly given the risk associated with sterility concerns in an injectable drug.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Lipotoxin Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is A3121 with an expiration date of 9/30/12.
The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility. The agency classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Lipotoxin Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — 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)
- A3121 Exp 9/30/12
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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