The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0848-2022·Announced 2022-05-11

Lidocaine Hydrochloride Topical Solution Recalled for Manufacturing Quality Deviations

McKesson Corporation is recalling Lidocaine Hydrochloride Topical Solution due to manufacturing deviations related to discontinuation of the stability study program. Approximately 81,757 bottles distributed nationwide are affected.

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 3/5 (High).

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: This is an FDA Class II recall due to CGMP deviations related to discontinued stability studies, representing a risk-of-harm situation where the product's long-term safety and efficacy cannot be assured. No illnesses or injuries have been reported.

Plain-English summary

McKesson Corporation is recalling Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottles (Rx only), manufactured by Teligent Pharma, Inc., Buena, New Jersey.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing firm discontinued its stability study program. Stability studies are used to demonstrate that products maintain their labeled potency and quality throughout their shelf life.

Approximately 81,757 bottles have been distributed nationwide in the United States, Guam, and the Northern Mariana Islands. The affected lot numbers and expiration dates are: Lot 15597 (Exp. 05/31/2023), Lot 16305 (Exp. 12/23/2023), Lot 16334 (Exp. 01/31/2024), Lot 16340 (Exp. 01/31/2024), Lot 16346 (Exp. 01/31/2024), Lot 16356 (Exp. 01/31/2024), and Lot 16357 (Exp. 01/31/2024).

Patients who have received this product should contact their healthcare provider for guidance on alternative treatments. Unused product should be returned to the dispensing pharmacy.

The recalled product

Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
Manufacturer
McKesson Corporation dba McKesson Drug Company
Category
Drug — Topical Anesthetic
Hazard
Affected units
81,757

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 (10)

  • Lots: 15597
  • Exp.: 05/31/2023
  • 16305
  • Exp.: 12/23/2023
  • 16334
  • Exp.: 01/31/2024
  • 16340
  • 16346 Exp.: 01/31/2024
  • 16356
  • 16357

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 5 recalled by McKesson Corporation dba McKesson Drug Company 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 5 products in this recall →

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