Aminocaproic Acid Injection Recalled for Sterility Concerns
Olympia Pharmacy is recalling Aminocaproic Acid 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, particularly given the risk of sterility failure in an injectable medication.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one lot of Aminocaproic Acid 250 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to compound the medication.
The specific product affected is identified by code B3727 with an expiration date of 8/7/13. The product was distributed nationwide and to Puerto Rico.
The reason for the recall is a lack of assurance of sterility. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Aminocaproic Acid 250 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)
- B3727 Exp 8/7/13
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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