Pharmedium Recalls Hydromorphone HCl Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl in Sodium Chloride 0.9% due to a lack of sterility assurance.
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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Pharmedium Services, LLC is recalling Hydromorphone HCl in Sodium Chloride 0.9% in all doses, strengths, and packaging. The recall is being conducted because of a lack of sterility assurance for the product.
The recall covers all lots remaining within their expiration 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 the recalling firm for further instructions.
The recalled product
- Product
- HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, 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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