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Class I: serious health riskTerminated

Teligent Pharma Lidocaine Hydrochloride Topical Solution 4% Recall

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Onl…

Teligent Pharma, Inc. · Buena, NJ

Risk level
Class I
Reported by FDA
Dec 22, 2021
Recall ID
D-0280-2022
Check your lot numberHow we source this data

Summary

Teligent Pharma recalled Lidocaine Hydrochloride Topical Solution 4% starting Oct 12, 2021. The FDA classified it as Class I (serious health risk) and published enforcement report D-0280-2022 on Dec 22, 2021. Reason: Superpotent Drug. Status: Terminated.

Why it was recalled

Superpotent Drug

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0280-2022
Classification
Class I
Status
Terminated
Recall initiated
Oct 12, 2021
FDA report date
Dec 22, 2021
Quantity
52,104 glass bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Teligent Pharma, Inc.

Original FDA data

Every field from FDA enforcement report D-0280-2022, exactly as published.

Show all FDA fields
City
Buena
State
NJ
Status
Terminated
Country
United States
Event ID
88850
Address
105 Lincoln Avenue
Code information
Lot #: 13262, Exp. 03/2022; 14217, Exp. 08/2022
Postal code
08310
Report date
Dec 22, 2021
Product type
Drugs
Recall number
D-0280-2022
Classification
Class I
Recalling firm
Teligent Pharma, Inc.
Product quantity
52,104 glass bottles
Termination date
Jun 18, 2024
Reason for recall
Superpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide within the United States
Recall initiation date
Oct 12, 2021
Initial firm notification
Press Release
Center classification date
Dec 13, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0280-2022, published Dec 22, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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