Pharmedium Recalls Fentanyl and Ropivacaine Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling Fentanyl Citrate and Ropivacaine HCl injections because of a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.
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 an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, doses, and packaging. The recall is being conducted due to a lack of sterility assurance for the product.
The recall includes all lots of the medication that are still within their expiry dates. The product was distributed nationwide in the United States.
Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return it or obtain a replacement.
The recalled product
- Product
- Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
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)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Pharmedium Services, LLC 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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