The Recall Desk
HighFDA (Drugs)·D-1004-2022·Announced 2022-06-15

Lidocaine Patch 5% Recalled for Temperature Exposure During Distribution

McKesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during storage and distribution. Affected patches may not function properly. Patients should consult their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for cGMP deviations (temperature abuse) affecting pharmaceutical product storage and stability. Temperature exposure to medication patches poses a risk to drug stability and efficacy. No illnesses or injuries reported. Meets High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Lidocaine Patch 5%, 30-count boxes (NDC 42858-0118-30), distributed nationwide in the United States. The recall was initiated due to cGMP deviations involving temperature abuse during storage and distribution of the product.

Patches exposed to temperatures outside appropriate ranges may have compromised stability and integrity. This could affect the patch's ability to deliver the prescribed dose of lidocaine effectively and safely as intended.

Patients currently using recalled product should consult their healthcare provider before stopping treatment or continuing use. Healthcare providers and pharmacists who have distributed or dispensed this product should stop dispensing immediately and follow McKesson's recall instructions.

The recalled product

Product
Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Topical Patch
Hazard
  • temperature-abuse
  • cgmp-deviation

Distribution

Distributed nationwide across the United States.

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