Pharmedium Recalls Phenylephrine HCl Injections Due To Sterility Concerns
Pharmedium Services, LLC is recalling all lots of Phenylephrine 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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling all strengths, doses, and packaging of Phenylephrine HCl in 0.9% Sodium Chloride. The recall is being conducted because the product lacks sterility assurance. The affected product is distributed nationwide in the United States.
The recall includes all lots of the medication that are still within their expiration dates. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- Phenylephrine 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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