Pharmedium Recalls Hydromorphone HCl Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl Injection 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, FDA Class II recalls involving hospitalization reports or significant injury/property damage are rated as Severe (4). While specific injury reports are not detailed in the snippet, the lack of sterility assurance in an injectable drug presents a significant risk of infection, aligning with the Severe criteria for Class II recalls with potential for serious harm.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling all lots of Hydromorphone HCl Injection in all strengths, doses, and packaging. The recall is being conducted because of a lack of sterility assurance in the product. The affected products are distributed nationwide in the United States.
The recall includes all lots remaining within their expiration dates. The source text does not specify the number of units recalled or the specific dates of distribution. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the recalled Hydromorphone HCl Injection and contact their pharmacist or the recalling firm for further instructions. Consumers should not attempt to use the product if they have any concerns about its sterility.
The recalled product
- Product
- HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
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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