Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Nystatin and Triamcinolone Acetonide Cream Recalled for Stability Failure

Agency Publication Date: October 5, 2018

Summary

Dr. Reddy's Laboratories, Inc. is recalling 35,020 tubes of Nystatin and Triamcinolone Acetonide Cream, USP (100,000 units/gm & 1 mg/gm) because the product failed stability testing. Specifically, an out-of-specification result was found regarding the composition of Nystatin, which means the medication may not maintain its required strength or quality through its expiration date. This prescription-only cream is used to treat fungal skin infections, and the recall affects 15g, 30g, and 60g tubes distributed nationwide in the United States.

Risk

Because the Nystatin composition failed stability standards, the medication may be less effective than intended. This could lead to a failure to properly treat the underlying fungal infection or result in inconsistent dosing for patients.

What You Should Do

Check your prescription cream tube and outer packaging for 'Nystatin and Triamcinolone Acetonide Cream, USP' and the NDC numbers 43598-431-44 (15g), 43598-431-30 (30g), or 43598-431-60 (60g).
Identify if your tube matches the following lot numbers and expiration dates: for 15g tubes, lots D06017, D06018 (Exp 9/18) and D06028 (Exp 10/18); for 30g tubes, lots D06014, D06015, D06016 (Exp 9/18) and D06024, D06025, D06026, D06027 (Exp 10/2018); for 60g tubes, lots D06011, D06012, D06013 (Exp 9/18) and D06020, D06021, D06022, D06023 (Exp 10/2018).
Contact your healthcare provider or pharmacist for guidance if you are currently using this medication to determine if a replacement treatment is necessary.
Return any unused product to the pharmacy where it was purchased for a refund and contact Dr. Reddy's Laboratories, Inc. at their Princeton, NJ headquarters if you have further questions.
For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation.

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

Affected Products

Product: Nystatin and Triamcinolone Acetonide Cream, USP (15 g tube)

Model:

NDC 43598-431-44

Lot Numbers:

D06017 (Exp 9/18)

D06018 (Exp 9/18)

D06028 (Exp 10/18)

Date Ranges: Expiration 9/18, Expiration 10/18

Product: Nystatin and Triamcinolone Acetonide Cream, USP (30 g tube)

Model:

NDC 43598-431-30

Lot Numbers:

D06014 (Exp 9/18)

D06015 (Exp 9/18)

D06016 (Exp 9/18)

D06024 (Exp 10/2018)

D06025 (Exp 10/2018)

D06026 (Exp 10/2018)

D06027 (Exp 10/2018)

Date Ranges: Expiration 9/18, Expiration 10/2018

Product: Nystatin and Triamcinolone Acetonide Cream, USP (60 g tube)

Model:

NDC 43598-431-60

Lot Numbers:

D06011 (Exp 9/18)

D06012 (Exp 9/18)

D06013 (Exp 9/18)

D06020 (Exp 10/2018)

D06021 (Exp 10/2018)

D06022 (Exp 10/2018)

D06023 (Exp 10/2018)

Date Ranges: Expiration 9/18, Expiration 10/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81083

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India

Units Affected: 35020 tubes

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 prescription cream tube and outer packaging for 'Nystatin and Triamcinolone Acetonide Cream, USP' and the NDC numbers 43598-431-44 (15g), 43598-431-30 (30g), or 43598-431-60 (60g).

Identify if your tube matches the following lot numbers and expiration dates: for 15g tubes, lots D06017, D06018 (Exp 9/18) and D06028 (Exp 10/18); for 30g tubes, lots D06014, D06015, D06016 (Exp 9/18) and D06024, D06025, D06026, D06027 (Exp 10/2018); for 60g tubes, lots D06011, D06012, D06013 (Exp 9/18) and D06020, D06021, D06022, D06023 (Exp 10/2018).

Contact your healthcare provider or pharmacist for guidance if you are currently using this medication to determine if a replacement treatment is necessary.

Return any unused product to the pharmacy where it was purchased for a refund and contact Dr. Reddy's Laboratories, Inc. at their Princeton, NJ headquarters if you have further questions.

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

Affected Products

Product: Nystatin and Triamcinolone Acetonide Cream, USP (15 g tube)

Model:

NDC 43598-431-44

Lot Numbers:

D06017 (Exp 9/18)

D06018 (Exp 9/18)

D06028 (Exp 10/18)

Date Ranges: Expiration 9/18, Expiration 10/18

Product: Nystatin and Triamcinolone Acetonide Cream, USP (30 g tube)

Model:

NDC 43598-431-30

Lot Numbers:

D06014 (Exp 9/18)

D06015 (Exp 9/18)

D06016 (Exp 9/18)

D06024 (Exp 10/2018)

D06025 (Exp 10/2018)

D06026 (Exp 10/2018)

D06027 (Exp 10/2018)

Date Ranges: Expiration 9/18, Expiration 10/2018

Product: Nystatin and Triamcinolone Acetonide Cream, USP (60 g tube)

Model:

NDC 43598-431-60

Lot Numbers:

D06011 (Exp 9/18)

D06012 (Exp 9/18)

D06013 (Exp 9/18)

D06020 (Exp 10/2018)

D06021 (Exp 10/2018)

D06022 (Exp 10/2018)

D06023 (Exp 10/2018)

Date Ranges: Expiration 9/18, Expiration 10/2018