Pharmedium Recalls Ketamine HCl Injection Due to Sterility Assurance Concerns
Pharmedium Services, LLC is recalling all lots of Ketamine HCl Injection because of a lack of sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.
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. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance (which implies potential for serious injury or infection) corresponds to a severity score of 4 (Severe), especially given the structural nature of the defect in a sterile injectable drug.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling all lots of Ketamine HCl Injection in all strengths, doses, and packaging. The recall is being conducted due to a lack of sterility assurance for the product.
The affected product is distributed nationwide in the United States. The recall includes all lots remaining within their expiration dates. No specific lot numbers or quantities are listed in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Ketamine HCl Injection in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- 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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