Olympia Pharmacy Recalls Fluphenazine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Fluphenazine 25 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.
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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Fluphenazine 25 mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, FL. The recall is due to FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility.
The affected product is identified by code C5428 with an expiration date of 9/4/13. The distribution pattern is listed as Nationwide and PR. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Fluphenazine 25 mg/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)
- C5428 Exp 9/4/13
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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