Gentamicin Sulfate Irrigation Solution Recalled for Sterility Assurance Concerns
Creative Compounds is recalling Gentamicin Sulfate irrigation solution due to quality control issues affecting sterility assurance identified during an FDA inspection.
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. According to the rubric, FDA Class II recalls with potential risks to sterility assurance (which can lead to serious infection) fall under the 'Severe' category, especially given the lack of explicit 'no injury' statements and the nature of the hazard.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling all lots of sterile products compounded by the pharmacy that are not expired. The recall is initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The specific product identified in the recall notice is Gentamicin Sulfate, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle. The affected lot number is 20140917@27 with a discard date of 10/22/2014. The product was distributed in Oregon and Washington.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
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 (2)
- Lot #: 20140917@27
- discard date: 10/22/2014
Distribution
Part of a larger recall action
This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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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