Pharmedium Recalls Nicardipine HCl Infusions Due to Sterility Concerns
Pharmedium Services, LLC is recalling all lots of Nicardipine HCl in 0.9% Sodium Chloride 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 source text identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance in an injectable medication corresponds to a score of 4 (Severe).
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling all strengths, doses, and packaging of Nicardipine HCl in 0.9% Sodium Chloride. 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 of the medication that are remaining within their expiration dates.
Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. 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.
The recalled product
- Product
- Nicardipine 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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