Medications & Supplements/Topical Products

Teva Pharmaceuticals USA: Fluocinolone Acetonide Topical Solution Recalled for Subpotency and Impurities

Agency Publication Date: July 6, 2018

Summary

Teva Pharmaceuticals has recalled 27,803 bottles of Fluocinolone Acetonide Topical Solution, USP, 0.01% (60 mL), a prescription medication used to treat various skin conditions. This recall was initiated because laboratory testing found the drug was subpotent, meaning it contained less of the active ingredient than required, and had levels of impurities (degradants) that exceeded safety specifications. These bottles were distributed nationwide in the United States and Puerto Rico.

Risk

A subpotent medication may not be effective in treating the underlying skin condition, potentially leading to a lack of therapeutic benefit for the patient. Additionally, the presence of impurities beyond established safety limits could cause unexpected side effects or adverse reactions.

What You Should Do

Check your medication bottle for the product name Fluocinolone Acetonide Topical Solution, USP, 0.01% in a 60 mL size with NDC 0591-2990-60.
Verify if your bottle matches one of the affected lot numbers and expiration dates: Lot 1164898 (Exp 10/18); Lots 1164904 or 1164909 (Exp 11/18); Lot 1211396 (Exp 07/19); or Lots 1230808 or 1231127 (Exp 01/20).
If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options and to determine if your condition has been properly managed.
Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund and further instructions.
Contact Teva Pharmaceuticals USA or the distributor, Actavis Pharma, for additional information regarding the return process.
For general safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Guidance and product return

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

Affected Products

Product: Fluocinolone Acetonide Topical Solution, USP, 0.01% (60 mL)

Model:

NDC 0591-2990-60

Recall #: D-0909-2018

Lot Numbers:

1164898 (EXP 10/18)

1164904 (EXP 11/18)

1164909 (EXP 11/18)

1211396 (EXP 07/19)

1230808 (EXP 01/20)

1231127 (EXP 01/20)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80437

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 27,803 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

What You Should Do

Check your medication bottle for the product name Fluocinolone Acetonide Topical Solution, USP, 0.01% in a 60 mL size with NDC 0591-2990-60.

Verify if your bottle matches one of the affected lot numbers and expiration dates: Lot 1164898 (Exp 10/18); Lots 1164904 or 1164909 (Exp 11/18); Lot 1211396 (Exp 07/19); or Lots 1230808 or 1231127 (Exp 01/20).

If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options and to determine if your condition has been properly managed.

Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund and further instructions.

Contact Teva Pharmaceuticals USA or the distributor, Actavis Pharma, for additional information regarding the return process.

For general safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.