Lidocaine Hydrochloride Solution
FDA Recall NDC 63739-997
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Lidocaine Hydrochloride (NDC 63739-997). A significant event, classified as Class II, was initiated on Nov 30, 2021 by Mckesson Corporation Dba Sky Packaging. The reported reason for this action was: "Superpotent Drug: Minimally superpotent"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Superpotent Drug: Minimally superpotent
Nov 30, 2021
Jan 05, 2022
7,176 bottles
Recall Profile & Regulatory Data
Event ID
89135
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teligent Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Product Description
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
Batch or Lot Expiration Information
Lot# : 15594, Exp Date 05/2023
Affected Packages Involved in this Recall
63739-997-64Product
Class I Ongoing
Superpotent Drug
Nov 30, 2021
Jan 05, 2022
6,816 bottles
Recall Profile & Regulatory Data
Event ID
89135
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Teligent Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Product Description
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
Batch or Lot Expiration Information
Lot# : 16345, Exp. Date 01/2024
Affected Packages Involved in this Recall
63739-997-64Product
Class II Terminated
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Oct 12, 2021
Dec 22, 2021
7,008 glass bottles
Recall Profile & Regulatory Data
Event ID
88850
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teligent Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 18, 2024
Product Description
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.
Batch or Lot Expiration Information
Lot# : 16306, Exp. Date 01/2024.
Affected Packages Involved in this Recall
63739-997-64Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
