FDA recalls Lidocaine-Prilocaine topical anesthetic cream for temperature abuse
McKesson Medical-Surgical is recalling Lidocaine and Prilocaine Cream due to cGMP deviations involving temperature abuse during distribution. The recall affects 23 tubes distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a cGMP deviation related to temperature abuse during distribution—a precautionary manufacturing issue without evidence of actual product failure or patient harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Lidocaine and Prilocaine Cream, 2.5%/2.5%, in 5-gram tubes (NDC 0168-0357-56) distributed nationwide. The recall involves 23 tubes that were distributed in the United States.
The reason for the recall is a cGMP (current Good Manufacturing Practice) deviation related to temperature abuse during storage and distribution of the product. The specific nature of the risk posed by this temperature exposure is not detailed in the available recall information.
McKesson was unable to identify the specific lot numbers for individual consignees. Customers were notified individually with the dates when product was distributed to them and the dates when impacted product may have been shipped.
The recalled product
- Product
- LIDOCAINE AND PRILOCAINE (LIDOCAINE AND PRILOCAINE)
- Brand
- LIDOCAINE AND PRILOCAINE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Anesthetic
- Hazard
- temperature-abuse
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0301680357300
Distribution
Distributed nationwide across the United States.
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