Dexpanthenol Injection Recalled for Lack of Sterility Assurance
Olympia Pharmacy is recalling Dexpanthenol 250 mg/ml Injection due to FDA inspection findings regarding 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures are categorized as Severe (Score 4), as they are not Class I but involve potential serious health consequences.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Dexpanthenol 250 mg/ml Injection. The product was distributed nationwide and in Puerto Rico. The specific code for the recalled product is I5406 with an expiration date of 9/30/13.
The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to ensure the sterility of the product. The source text does not report any specific illnesses or injuries associated with the use of this product.
Consumers who possess this product should stop using it and contact Olympia Pharmacy for further instructions or a refund.
The recalled product
- Product
- Dexpanthenol 250 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)
- I5406 Exp 9/30/13
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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