Olympia Pharmacy Recalls Metabolase Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Metabolase 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, fitting the 'High' severity criteria.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling two units of Metabolase Injection. 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 affected product includes Metabolase Injection with lot codes B0101 (expiration date 10/31/13) and B0013 (expiration date 8/13/13). The product was distributed nationwide and in Puerto Rico.
Consumers who have this product should stop using it and contact Olympia Pharmacy for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Compounded Injection
- Affected units
- 2
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)
- B0101 Exp 10/31/13 and B0013 Exp 8/13/13
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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