Olympia Pharmacy Recalls Aminocaproic Acid Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Aminocaproic Acid 0.5mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Aminocaproic Acid 0.5mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, FL. The recall involves one unit with the code B5505 and an expiration date of 08/06/13.
The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and a lack of assurance of sterility. The agency has classified this as a Class II recall.
The product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Aminocaproic Acid 0.5mg/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)
- B5505 Exp. 08/06/13
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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