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Class III: unlikely to cause harmTerminated

Teligent Pharma Erythromycin Topical Gel Recall

Erythromycin Topical Gel, 2%

Teligent Pharma, Inc. · Buena, NJ

Risk level
Class III
Reported by FDA
Jul 28, 2021
Recall ID
D-0690-2021
Check your lot numberHow we source this data

Summary

Teligent Pharma recalled Erythromycin Topical Gel starting Jun 22, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0690-2021 on Jul 28, 2021. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,

Lot numbers, UPCs & expiration codes

1) NDC 52565-033-30 Lot 14010, Exp July 2021; 2) NDC 52565-033-60 Lot 13865, Exp June 2021; Lot 14011, Exp July 2021.

Where it was sold

Nationwide

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-0690-2021
Classification
Class III
Status
Terminated
Recall initiated
Jun 22, 2021
FDA report date
Jul 28, 2021
Quantity
22,824 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Teligent Pharma, Inc.

Original FDA data

Every field from FDA enforcement report D-0690-2021, exactly as published.

Show all FDA fields
City
Buena
State
NJ
Status
Terminated
Country
United States
Event ID
88145
Address
105 Lincoln Avenue
Code information
1) NDC 52565-033-30 Lot 14010, Exp July 2021; 2) NDC 52565-033-60 Lot 13865, Exp June 2021; Lot 14011, Exp July 2021.
Postal code
08310
Report date
Jul 28, 2021
Product type
Drugs
Recall number
D-0690-2021
Classification
Class III
Recalling firm
Teligent Pharma, Inc.
Product quantity
22,824 tubes
Termination date
Jul 3, 2024
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,
Distribution pattern
Nationwide
Recall initiation date
Jun 22, 2021
Initial firm notification
Letter
Center classification date
Jul 19, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0690-2021, published Jul 28, 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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