Medications & Supplements/Prescription Drugs

Fludrocortisone Acetate Tablets Recalled for Impurity Specifications

Agency Publication Date: July 16, 2024

Summary

Teva Pharmaceuticals USA, Inc. is recalling 116,144 bottles of Fludrocortisone Acetate Tablets, USP 0.1mg (a generic medication). The recall was issued because laboratory testing found that certain chemical impurities and related substances were present in the medication above allowed safety limits. This recall affects 100-count bottles of the medication distributed nationwide throughout the United States and Puerto Rico.

Risk

The presence of unknown impurities and API-related substances above specification limits can potentially impact the safety or effectiveness of the drug. While no specific injuries have been reported, consumers should consult their doctor if they have experienced any health problems while taking this medication.

What You Should Do

This recall affects Fludrocortisone Acetate Tablets, USP 0.1mg, sold in 100-count bottles under the Teva Pharmaceuticals brand with NDC 0555-0997-02.
Check your medication bottle for the following lot numbers and expiration dates: CNSDH (Exp. 6/30/2024); CNWVM or CNWWH (Exp. 07/31/2024); CNXKW, CNXKY, CNXMB, or CNXMH (Exp. 09/30/2024); CPBTP or CPBTV (Exp. 11/30/2024).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fludrocortisone Acetate Tablets, USP 0.1mg (100-count bottle)

Variants: 0.1mg, 100 Tablets per bottle

Lot Numbers:

CNSDH (Exp. 6/30/2024)

CNWVM (Exp. 07/31/2024)

CNWWH (Exp. 07/31/2024)

CNXKW (Exp. 09/30/2024)

CNXKY (Exp. 09/30/2024)

CNXMB (Exp. 09/30/2024)

CNXMH (Exp. 09/30/2024)

CPBTP (Exp. 11/30/2024)

CPBTV (Exp. 11/30/2024)

NDC:

0555-0997-02

Manufactured in Canada by Patheon, Inc. and distributed by Teva Pharmaceuticals USA, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94900

Status: Active

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: Pharmacies; Healthcare Providers

Manufactured In: Canada

Units Affected: 116,144 bottles

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

Risk

What You Should Do

This recall affects Fludrocortisone Acetate Tablets, USP 0.1mg, sold in 100-count bottles under the Teva Pharmaceuticals brand with NDC 0555-0997-02.

Check your medication bottle for the following lot numbers and expiration dates: CNSDH (Exp. 6/30/2024); CNWVM or CNWWH (Exp. 07/31/2024); CNXKW, CNXKY, CNXMB, or CNXMH (Exp. 09/30/2024); CPBTP or CPBTV (Exp. 11/30/2024).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fludrocortisone Acetate Tablets, USP 0.1mg (100-count bottle)

Variants: 0.1mg, 100 Tablets per bottle

Lot Numbers:

CNSDH (Exp. 6/30/2024)

CNWVM (Exp. 07/31/2024)

CNWWH (Exp. 07/31/2024)

CNXKW (Exp. 09/30/2024)

CNXKY (Exp. 09/30/2024)

CNXMB (Exp. 09/30/2024)

CNXMH (Exp. 09/30/2024)

CPBTP (Exp. 11/30/2024)

CPBTV (Exp. 11/30/2024)

NDC:

0555-0997-02

Manufactured in Canada by Patheon, Inc. and distributed by Teva Pharmaceuticals USA, Inc.