Multi-event October 2021 FDA Recall Lidocaine Hydrochloride by Teligent Pharma, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Teligent Pharma, Inc. on October 12, 2021 for the product Lidocaine Hydrochloride. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0281-2022 TERMINATED D-0280-2022 TERMINATED D-0279-2022 TERMINATED

Recall Number: D-0281-2022

Reason for Recall
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.
Initiated
10-12-2021
Reported
12-22-2021
Quantity
14,664 glass bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88850
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teligent Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-18-2024
Product Description About Product Description
Full technical description of the product.
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

Batch or Lot Expiration Information

Lot# : 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022

Recall Number: D-0280-2022

Reason for Recall
Superpotent Drug
Initiated
10-12-2021
Reported
12-22-2021
Quantity
52,104 glass bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88850
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teligent Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-18-2024
Product Description About Product Description
Full technical description of the product.
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

Batch or Lot Expiration Information

Lot# : 13262, Exp. 03/2022; 14217, Exp. 08/2022

Recall Number: D-0279-2022

Reason for Recall
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.
Initiated
10-12-2021
Reported
12-22-2021
Quantity
7,008 glass bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88850
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teligent Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-18-2024
Product Description About Product Description
Full technical description of the product.
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

63739-997-64 Lidocaine Hydrochloride