Medications & Supplements/Topical Products

Teligent Pharma, Inc.: Fluocinonide Ointment Recalled for Failed Impurity and Degradation Limits

Agency Publication Date: November 5, 2020

Summary

Teligent Pharma, Inc. is recalling 36,790 tubes of Fluocinonide Ointment USP, 0.05% because testing revealed the presence of a specific impurity (Fluocinolone Acetonide) that exceeds the allowed quality standards. This recall affects three different tube sizes: 15 gram, 30 gram, and 60 gram packages distributed nationwide. Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for guidance.

Risk

The product does not meet chemical purity specifications due to the presence of an out-of-specification degradation product. This can reduce the effectiveness of the medication or result in an inconsistent treatment experience for skin conditions.

What You Should Do

Check your medicine cabinet for Fluocinonide Ointment USP, 0.05% in 15g, 30g, or 60g tubes with the NDC number 52565-0040 and the specific lot numbers and expiration dates listed.
For 15g tubes (NDC 52565-0040-15), look for lot 12250 (Exp 10/2020), 15039 (Exp 1/2022), or 15573 (Exp 7/2022).
For 30g tubes (NDC 52565-0040-30), look for lot 12250 (Exp 10/2020), 14589 or 14848 (Exp 12/2021), 15039 (Exp 1/2022), or 15245 (Exp 2/2022).
For 60g tubes (NDC 52565-0040-60), look for lot 12241 or 12249 (Exp 10/2020), 14222 (Exp 8/2021), 15039 (Exp 1/2022), 15037 or 15246 (Exp 2/2022), 15340 (Exp 3/2022), or 15387 (Exp 4/2022).
Stop using the affected ointment immediately and contact your healthcare provider or pharmacist for medical advice or a replacement prescription.
Return any unused product to the pharmacy where you purchased it for a refund and contact Teligent Pharma, Inc. at their Buena, New Jersey facility for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Full Refund

Healthcare consultation and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fluocinonide Ointment USP 0.05% (15 gm tube)

Model:

NDC 52565-0040-15

Recall #: D-0064-2021

Lot Numbers:

12250 (Exp 10/2020)

15039 (Exp 1/2022)

15573 (Exp 7/2022)

Date Ranges: Expiration 10/2020, Expiration 1/2022, Expiration 7/2022

Product: Fluocinonide Ointment USP 0.05% (30 gm tube)

Model:

NDC 52565-0040-30

Recall #: D-0064-2021

Lot Numbers:

12250 (Exp 10/2020)

14589 (Exp 12/2021)

14848 (Exp 12/2021)

15039 (Exp 1/2022)

15245 (Exp 2/2022)

Date Ranges: Expiration 10/2020, Expiration 12/2021, Expiration 1/2022, Expiration 2/2022

Product: Fluocinonide Ointment USP 0.05% (60 gram tube)

Model:

NDC 52565-0040-60

Recall #: D-0064-2021

Lot Numbers:

12241 (Exp 10/2020)

12249 (Exp 10/2020)

14222 (Exp 8/2021)

15039 (Exp 1/2022)

15037 (Exp 2/2022)

15246 (Exp 2/2022)

15340 (Exp 3/2022)

15387 (Exp 4/2022)

Date Ranges: Expiration 10/2020, Expiration 8/2021, Expiration 1/2022, Expiration 2/2022, Expiration 3/2022, Expiration 4/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86508

Status: Resolved

Manufacturer: Teligent Pharma, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 36,790 tubes

Distributed To: Nationwide

Agency Last Updated: November 13, 2020

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medicine cabinet for Fluocinonide Ointment USP, 0.05% in 15g, 30g, or 60g tubes with the NDC number 52565-0040 and the specific lot numbers and expiration dates listed.

For 15g tubes (NDC 52565-0040-15), look for lot 12250 (Exp 10/2020), 15039 (Exp 1/2022), or 15573 (Exp 7/2022).

For 30g tubes (NDC 52565-0040-30), look for lot 12250 (Exp 10/2020), 14589 or 14848 (Exp 12/2021), 15039 (Exp 1/2022), or 15245 (Exp 2/2022).

For 60g tubes (NDC 52565-0040-60), look for lot 12241 or 12249 (Exp 10/2020), 14222 (Exp 8/2021), 15039 (Exp 1/2022), 15037 or 15246 (Exp 2/2022), 15340 (Exp 3/2022), or 15387 (Exp 4/2022).

Stop using the affected ointment immediately and contact your healthcare provider or pharmacist for medical advice or a replacement prescription.

Return any unused product to the pharmacy where you purchased it for a refund and contact Teligent Pharma, Inc. at their Buena, New Jersey facility for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Fluocinonide Ointment USP 0.05% (15 gm tube)

Model:

NDC 52565-0040-15

Recall #: D-0064-2021

Lot Numbers:

12250 (Exp 10/2020)

15039 (Exp 1/2022)

15573 (Exp 7/2022)

Date Ranges: Expiration 10/2020, Expiration 1/2022, Expiration 7/2022

Product: Fluocinonide Ointment USP 0.05% (30 gm tube)

Model:

NDC 52565-0040-30

Recall #: D-0064-2021

Lot Numbers:

12250 (Exp 10/2020)

14589 (Exp 12/2021)

14848 (Exp 12/2021)

15039 (Exp 1/2022)

15245 (Exp 2/2022)

Date Ranges: Expiration 10/2020, Expiration 12/2021, Expiration 1/2022, Expiration 2/2022

Product: Fluocinonide Ointment USP 0.05% (60 gram tube)

Model:

NDC 52565-0040-60

Recall #: D-0064-2021

Lot Numbers:

12241 (Exp 10/2020)

12249 (Exp 10/2020)

14222 (Exp 8/2021)

15039 (Exp 1/2022)

15037 (Exp 2/2022)

15246 (Exp 2/2022)

15340 (Exp 3/2022)

15387 (Exp 4/2022)

Date Ranges: Expiration 10/2020, Expiration 8/2021, Expiration 1/2022, Expiration 2/2022, Expiration 3/2022, Expiration 4/2022