Multi-event November 2021 FDA Recall Lidocaine Hydrochloride by Teligent Pharma, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Teligent Pharma, Inc. on November 30, 2021 for the product Lidocaine Hydrochloride. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0296-2022
Superpotent Drug: Minimally superpotent
11-30-2021
01-05-2022
7,176 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0295-2022
Superpotent Drug
11-30-2021
01-05-2022
6,816 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
