Gentamicin Sulfate Irrigation Solution Recalled for Sterility Assurance Concerns
Oregon Compounding Centers 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, and the hazard involves a lack of sterility assurance in a sterile product, which poses a significant risk of serious injury or infection.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of Gentamicin Sulfate, 480mg/1000mL, solution for irrigation. The affected product is packaged in 300 mL plastic bottles and was distributed in Oregon and Washington.
The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility assurance of sterile products compounded by the pharmacy. The recall covers all lots of sterile products compounded by the pharmacy that are not expired.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The specific lot number identified in the recall notice is 20140912@29/150, with a discard date of 10/16/2014.
The recalled product
- Product
- GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Antibiotic
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 #: 20140912@29/150
- discard date: 10/16/2014
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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