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Class III: unlikely to cause harmTerminated

Teligent Pharma Lidocaine Ointment Recall

Lidocaine Ointment USP, 5%

Teligent Pharma, Inc. · Buena, NJ

Risk level
Class III
Reported by FDA
Apr 21, 2021
Recall ID
D-0331-2021
Check your lot numberHow we source this data

Summary

Teligent Pharma recalled Lidocaine Ointment starting Mar 29, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0331-2021 on Apr 21, 2021. Reason: Failed Stability Specifications: product did not meet viscosity results. Status: Terminated.

Why it was recalled

Failed Stability Specifications: product did not meet viscosity results.

Product description

Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.

Lot numbers, UPCs & expiration codes

Lot 13269, Exp March 2021

Where it was sold

Nationwide in the USA

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-0331-2021
Classification
Class III
Status
Terminated
Recall initiated
Mar 29, 2021
FDA report date
Apr 21, 2021
Quantity
62,040 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Teligent Pharma, Inc.

Original FDA data

Every field from FDA enforcement report D-0331-2021, exactly as published.

Show all FDA fields
City
Buena
State
NJ
Status
Terminated
Country
United States
Event ID
87631
Address
105 Lincoln Avenue
Code information
Lot 13269, Exp March 2021
Postal code
08310
Report date
Apr 21, 2021
Product type
Drugs
Recall number
D-0331-2021
Classification
Class III
Recalling firm
Teligent Pharma, Inc.
Product quantity
62,040 tubes
Termination date
Jul 3, 2024
Reason for recall
Failed Stability Specifications: product did not meet viscosity results.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.
Distribution pattern
Nationwide in the USA
Recall initiation date
Mar 29, 2021
Initial firm notification
Letter
Center classification date
Apr 12, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0331-2021, published Apr 21, 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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