Pharmedium Recalls Ketamine HCl Injection Due to Sterility Assurance Concerns
Pharmedium Services, LLC is recalling all lots of Ketamine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or potentially serious health consequences like lack of sterility assurance in injectable drugs, are classified as Severe (Score 4).
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling all lots of Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. The recall is being conducted because of a lack of sterility assurance for the product.
The affected product is distributed nationwide in the United States. The recall includes all lots that remain within their expiration dates. No specific lot numbers, quantities, or dates of distribution are provided in the source text.
Healthcare providers and patients should stop using the recalled product and contact Pharmedium Services, LLC for further instructions or to arrange for a return or replacement. Consumers should consult their healthcare provider if they have questions regarding the use of this medication.
The recalled product
- Product
- Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
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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