New England Compounding Center Recalls Lidocaine Dextrose Due to Sterility Concerns
New England Compounding Center is recalling Lidocaine/Dextrose 5%/7.5% PF nationwide due to a lack of assurance of sterility.
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 assurance of sterility, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
New England Compounding Center, located in Framingham, MA, is recalling Lidocaine/Dextrose 5%/7.5% PF. The recall is being conducted because of a lack of assurance of sterility for the product.
The recall affects all lot codes of the product and is distributed nationwide. The U.S. Food and Drug Administration has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled product and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Medication
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 lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by New England Compounding Center 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.
See all 17 products in this recall →Related recalls
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