Pharmedium Recalls Ropivacaine HCl Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling Ropivacaine HCl Injection in all strengths and packaging due to a lack of sterility assurance.
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 and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling Ropivacaine HCl Injection in all strengths, doses, and packaging. 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. All lots remaining within their expiration dates are included in this recall.
Consumers and healthcare providers should stop using the recalled Ropivacaine HCl Injection and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Ropivacaine 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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