Medications & Supplements/Prescription Drugs

Lyne Laboratories, Inc.: Fluocinolone Acetonide Topical Oil Recalled for Being Subpotent

Agency Publication Date: April 26, 2018

Summary

Lyne Laboratories is recalling approximately 53,964 units of Fluocinolone Acetonide Topical Oil, 0.01%, which is used to treat skin, scalp, and ear conditions. This recall includes the Body Oil, Ear Drops, and Scalp Oil formulations sold under the Rising Pharmaceuticals brand. The medication was found to be subpotent, meaning it may not contain the full amount of active ingredient required, which could result in the treatment being less effective than intended. Consumers who have these medications should contact their healthcare provider or pharmacist, as the product may not adequately treat their symptoms.

Risk

The drug is subpotent, which means it may not deliver the required therapeutic dose of the corticosteroid medication to the affected area. This can lead to a lack of treatment efficacy and a potential worsening of the underlying skin or ear condition being treated.

What You Should Do

Check your medicine cabinet for Rising Pharmaceuticals Fluocinolone Acetonide Topical Oil 0.01% in 20 mL or 118.28 mL (4 fl. oz.) bottles.
For Body Oil (118.28 mL), look for NDC 64980-331-04, UPC 364980331043, and Lot numbers FR1603 or FR1604A with an expiration date of 05/2018.
For Ear Drops (20 mL), look for NDC 64980-329-20, UPC 364980329200, and Lot numbers FR1604B, FR1604C, or FR 1604D with an expiration date of 06/2018.
For Scalp Oil (118.28 mL), look for NDC 64980-330-04, UPC 364980330046, and Lot numbers FR1601 or FR1602 with an expiration date of 05/2018.
If you identify an affected product, contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement.
Return any unused product to the pharmacy where it was purchased for a refund and contact Lyne Laboratories for further instructions.
For additional questions, 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

Return to pharmacy for refund

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 Oil, 0.01% (Body Oil) (118.28 mL / 4 fl. oz.)

Model:

NDC 64980-331-04

UPC Codes:

364980331043

Lot Numbers:

FR1603 (Exp. 05/2018)

FR1604A (Exp. 05/2018)

Date Ranges: Exp. 05/2018

Product: Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) (20 mL)

Model:

NDC 64980-329-20

UPC Codes:

364980329200

Lot Numbers:

FR1604B (Exp. 06/2018)

FR1604C (Exp. 06/2018)

FR 1604D (Exp. 06/2018)

Date Ranges: Exp. 06/2018

Product: Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) (118.28 mL / 4 fl. oz.)

Model:

NDC 64980-330-04

UPC Codes:

364980330046

Lot Numbers:

FR1601 (Exp. 05/2018)

FR1602 (Exp. 05/2018)

Date Ranges: Exp. 05/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79860

Status: Resolved

Manufacturer: Lyne Laboratories, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 3 products (12572 units; 17939 units; 23453 units)

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 medicine cabinet for Rising Pharmaceuticals Fluocinolone Acetonide Topical Oil 0.01% in 20 mL or 118.28 mL (4 fl. oz.) bottles.

For Body Oil (118.28 mL), look for NDC 64980-331-04, UPC 364980331043, and Lot numbers FR1603 or FR1604A with an expiration date of 05/2018.

For Ear Drops (20 mL), look for NDC 64980-329-20, UPC 364980329200, and Lot numbers FR1604B, FR1604C, or FR 1604D with an expiration date of 06/2018.

For Scalp Oil (118.28 mL), look for NDC 64980-330-04, UPC 364980330046, and Lot numbers FR1601 or FR1602 with an expiration date of 05/2018.

If you identify an affected product, contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement.

Return any unused product to the pharmacy where it was purchased for a refund and contact Lyne Laboratories for further instructions.

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

Affected Products

Product: Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) (118.28 mL / 4 fl. oz.)

Model:

NDC 64980-331-04

UPC Codes:

364980331043

Lot Numbers:

FR1603 (Exp. 05/2018)

FR1604A (Exp. 05/2018)

Date Ranges: Exp. 05/2018

Product: Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) (20 mL)

Model:

NDC 64980-329-20

UPC Codes:

364980329200

Lot Numbers:

FR1604B (Exp. 06/2018)

FR1604C (Exp. 06/2018)

FR 1604D (Exp. 06/2018)

Date Ranges: Exp. 06/2018

Product: Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) (118.28 mL / 4 fl. oz.)

Model:

NDC 64980-330-04

UPC Codes:

364980330046

Lot Numbers:

FR1601 (Exp. 05/2018)

FR1602 (Exp. 05/2018)

Date Ranges: Exp. 05/2018