Pharmedium Recalls Bupivacaine HCl Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling Bupivacaine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers 297 bags distributed nationwide.
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 rating under the rubric. The hazard involves a lack of sterility assurance in an injectable medication, posing a significant risk of infection.
Plain-English summary
Pharmedium Services, LLC is recalling Bupivacaine HCl in 0.9% Sodium Chloride in all doses, strengths, and packaging. The recall is being conducted because of a lack of sterility assurance in the product.
The recall involves 297 bags of the medication. These products were distributed nationwide in the United States. The recall covers all lots that are remaining within their expiry dates.
Healthcare providers and consumers should stop using the recalled product and contact Pharmedium Services, LLC for further instructions or to arrange for a return.
The recalled product
- Product
- Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 297
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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