Pharmedium Recalls Lidocaine HCl Due to Sterility Assurance Concerns
Pharmedium Services, LLC is recalling all lots of Lidocaine HCl due to a lack of sterility assurance. The recall covers products distributed nationwide in the U.S.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While the specific injury reports are not detailed in the snippet, the 'lack of sterility assurance' for a drug product implies a significant risk of infection, aligning with the Severe classification for Class II drug recalls with potential for serious harm.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling Lidocaine HCl in all strengths, doses, and packaging. The recall is being conducted because of a lack of sterility assurance in the product. The affected products were distributed nationwide in the United States.
The recall includes all lots of the product that remain 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 Lidocaine HCl products and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Lidocaine HCl in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
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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