Gentamicin Sulfate Injection Recalled for Sterility Concerns
Olympia Pharmacy is recalling Gentamicin Sulfate 80 mg/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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While specific injury reports are not detailed in the snippet, the agency classification of Class II for a sterile injection product involving sterility assurance failures aligns with the Severe criteria for significant potential harm.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Gentamicin Sulfate 80 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during compounding.
The specific hazard identified is a lack of assurance of sterility. The affected product is identified by the code B5125 with an expiration date of 8/25/13. The product was distributed nationwide and in Puerto Rico.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Gentamicin Sulfate 80 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)
- B5125 Exp 8/25/13
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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