Gentamicin Injection Recalled for Lack of Sterility Assurance
Olympia Pharmacy is recalling Gentamicin 0.3% 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 are assigned a score of 4 (Severe), particularly when involving significant quality control failures like lack of sterility assurance in injectable medications.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Gentamicin 0.3% Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is A5308 with an expiration date of 6/30/13.
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 product. This is classified as an FDA Class II recall.
Consumers who possess this specific lot of Gentamicin 0.3% Injection should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Gentamicin 0.3% 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)
- A5308 Exp 6/30/13
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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