The Recall Desk
SevereFDA (Drugs)·D-120-2013·Announced 2013-01-09

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.

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 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

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 →