The Recall Desk
ModerateFDA (Drugs)·D-1068-2022·Announced 2022-06-15

Prescription Lidocaine Patches Recalled for Temperature-Related Quality Deviations

Mckesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during distribution that may affect product quality and efficacy. Affected patches were 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: FDA Class II recall for temperature-related manufacturing deviations with no reported illnesses or injuries. This is a precautionary quality-control recall.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling Lidocaine Patch 5% (30-count boxes, NDC 0591-3525-30), a prescription topical anesthetic manufactured by Teva Pharma USA. The recall is due to temperature abuse during distribution that resulted in current Good Manufacturing Practice (cGMP) deviations.

Temperature exposure during shipping and storage may compromise the product's quality and therapeutic efficacy. The firm was unable to identify specific lot numbers affected by the temperature deviation but issued letters to customers noting the dates when impacted product may have been shipped.

The affected product was distributed nationwide. Patients currently using affected patches should consult their healthcare provider about obtaining replacement medication. Unused patches should be returned to the dispensing pharmacy.

The recalled product

Product
LIDOCAINE (LIDOCAINE)
Brand
LIDOCAINE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • temperature-abuse
  • quality-degradation

Distribution

Distributed nationwide across the United States.