Olympia Pharmacy Recalls Amikacin Sulfate Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Amikacin Sulfate 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of 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, which corresponds to a 'Severe' rating under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two lots of Amikacin Sulfate 250 mg/ml Injection. The affected lots are identified by codes B5501 (expiration date 8/5/13) and B3025 (expiration date 12/31/13). The product was distributed nationwide and to Puerto Rico.
The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes. Specifically, the agency identified a lack of assurance of sterility for the compounded medication.
Consumers and healthcare providers should discontinue use of the recalled lots and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Antibiotic Injection
- Hazard
- 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)
- B5501 Exp 8/5/13 and B3025 Exp 12/31/13
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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