Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured
Summary
The FDA issued a Class I for Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL by Teligent Pharma, Inc.. Reason: Superpotent Drug.
Details
Source
Drug Recall
External ID
D-0295-2022
Action Date
2022-01-05
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: 16345, Exp. Date 01/2024
Quantity Affected: 6,816 bottles
Reason for Recall
Superpotent Drug
Distribution
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-30
Company
Buena, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Teligent Pharma, Inc. has 53 FDA actions in our database, including 53 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teligent Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teligent Pharma, Inc. have FDA actions?
Teligent Pharma, Inc. has 53 FDA actions in our database, including 53 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0295-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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