Pharmedium Recalls Fentanyl and Bupivacaine Injections Due to Sterility Concerns
Pharmedium Services, LLC is recalling Fentanyl Citrate and Bupivacaine HCl injections due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging 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 of harm (lack of sterility assurance in an injectable drug) corresponds to a severity score of 4 (Severe), particularly given the potential for serious injury from non-sterile injections.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, doses, and packaging. The recall is being conducted due to a lack of sterility assurance in the product.
The affected products were distributed nationwide in the United States. The recall includes all lots remaining within their expiration dates. No specific lot numbers or quantities are identified in the source text.
Consumers and healthcare providers should stop using the recalled products and contact Pharmedium Services, LLC for further instructions or a refund. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Fentanyl Citrate and Bupivacaine 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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