Olympia Pharmacy Recalls Phenobarbital Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Phenobarbital 62.5 mg/ml Injection because FDA inspection findings 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which carries a significant risk of serious injury or infection.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Phenobarbital 62.5 mg/ml Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the lack of assurance of sterility.
The affected product is identified by code B5128 with an expiration date of 8/28/13. The product was distributed nationwide and in Puerto Rico.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Phenobarbital 62. 5mg/ml 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)
- B5128 Exp 8/28/13
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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