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.
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: 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
- cgmp-deviation
- stability-concern
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.
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