Medications & Supplements/Topical Products

Blis-To-Sol, Yager's, and Other Topical Medications Recalled for CGMP Deviations

Agency Publication Date: August 24, 2023

Summary

Approximately 237,879 units of various topical medications and solutions are being recalled, including Blis-To-Sol Liquid (tolnaftate), Yager's Liniment, and Unguentine Ointment. These products were manufactured under conditions that deviated from current good manufacturing practices (CGMP), meaning their safety and quality standards cannot be guaranteed. The recall covers products distributed nationwide under several brands including Oakhurst, Larkspur, and CooperSurgical. There have been no reported incidents or injuries related to these products to date.

Risk

Failure to follow manufacturing standards can result in products that are contaminated, ineffective, or have inconsistent concentrations of active ingredients. While no injuries are reported, using medications that do not meet quality standards may fail to treat conditions properly or cause adverse skin reactions.

What You Should Do

This recall affects multiple brands of topical treatments including Blis-To-Sol Liquid, YAGER'S LINIMENT, ALCOLADO RELAMPAGO, Unguentine Ointment, activator concentrate, AstrinGyn vials, and Lugol's solution.
Identify if your product is affected by checking for UPC codes such as 011169200118 and 011169000046, or lot numbers like 9E098A and 0E267A. See the Affected Products section below for the full list of affected codes.
If you have health concerns after using these products, contact your healthcare provider or pharmacist immediately.
For retail products (Blis-To-Sol, Yager's, Alcolado, Unguentine, or activator), return any unused product to the place of purchase for a refund, throw it away, or contact Ecometics, Inc. directly for further instructions.
For clinical or hospital products (AstrinGyn and Lugol's vials), stop using the recalled product and contact your distributor to arrange for its return.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 3 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.

Option 3: Other Action

How to: For AstrinGyn and Lugol's clinical products: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Blis-To-Sol Liquid (Tolnaftate), 1%

Variants: 1 FLUID OZ. (29.5 mL) bottle, 1.85 FLUID OZ. (54.5 mL) bottle

UPC Codes:

011169200118

011169200125

Lot Numbers:

9E098A

Distributed by Oakhurst Company.

Product: YAGER'S LINIMENT (Camphor and Turpentine Oil)

Variants: 4 FL OZ (118 mL) bottle, 8 FL OZ (236 mL) bottle, Camphor 3.1%, Turpentine Oil 8.12%

UPC Codes:

011169000046

011169000084

Lot Numbers:

0E267A

Distributed by The Oakhurst Co.

Product: ALCOLADO RELAMPAGO (Menthol and Camphor)

Variants: 7 FLUID OZ (207 ml) bottle, 16 FLUID OZ (472 ml) bottle, Menthol 1%, Camphor 1.5%

UPC Codes:

718864201029

718864201104

Lot Numbers:

0E280A (exp 10/23)

0E318A (exp 11/23)

1E109A (exp 3/24)

1E141A (exp 5/24)

0E280A (exp 11/23)

1E141A (exp 3/24)

Distributed by The Larkspur Group, Inc.

Product: Unguentine Ointment

Variants: 1 OZ (28 g) tube Improved Formula, 1 OZ (28.3g) tube Maximum Strength

UPC Codes:

011169102160

011169112503

Lot Numbers:

1E113A (exp 4/24)

Distributed by Oakhurst Company.

Product: Activator Concentrate

Variants: 1 FL. OZ. bottle, Sodium Fluoride 0.96%

Lot Numbers:

1E175B (exp 6/24)

Manufactured for All USA Direct, LLC.

Product: AstrinGyn (Ferric Subsulfate) Aqueous

Variants: 8 gm Single Use Vials, 259 mg/g

Model:

6065

Lot Numbers:

2E144A (exp 11/2023)

2E157A (exp 11/2023)

2E270A (exp 3/2024)

2E300A (exp 4/2024)

NDC:

59365-6065-0

Manufactured for CooperSurgical.

Product: Lugol's (Strong Iodine Solution USP)

Variants: 8mL Single Use Vials

Model:

6064

Lot Numbers:

2E235A (exp 2/2024)

2E293A (exp 3/2024)

NDC:

59365-6064-0

Manufactured for CooperSurgical.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92857

Status: Resolved

Manufacturer: Ecometics, Inc.

Sold By: Oakhurst Company; The Larkspur Group, Inc.; All USA Direct, LLC; CooperSurgical

Manufactured In: United States

Units Affected: 7 products (a) 9816 bottles; b) 10,776 bottles; a) 5028 bottles; b) 9809 bottles; a) 52,879 bottles; b) 12,054 bottles; a) 6,120 tubes, b) 540 tubes; 32,583 bottles; 92,967 vials; 38,486 vials)

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 multiple brands of topical treatments including Blis-To-Sol Liquid, YAGER'S LINIMENT, ALCOLADO RELAMPAGO, Unguentine Ointment, activator concentrate, AstrinGyn vials, and Lugol's solution.

Identify if your product is affected by checking for UPC codes such as 011169200118 and 011169000046, or lot numbers like 9E098A and 0E267A. See the Affected Products section below for the full list of affected codes.

If you have health concerns after using these products, contact your healthcare provider or pharmacist immediately.

For retail products (Blis-To-Sol, Yager's, Alcolado, Unguentine, or activator), return any unused product to the place of purchase for a refund, throw it away, or contact Ecometics, Inc. directly for further instructions.

For clinical or hospital products (AstrinGyn and Lugol's vials), stop using the recalled product and contact your distributor to arrange for its return.

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

Your Remedy Options

You have 3 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.

Option 3: Other Action

How to: For AstrinGyn and Lugol's clinical products: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Blis-To-Sol Liquid (Tolnaftate), 1%

Variants: 1 FLUID OZ. (29.5 mL) bottle, 1.85 FLUID OZ. (54.5 mL) bottle

UPC Codes:

011169200118

011169200125

Lot Numbers:

9E098A

Distributed by Oakhurst Company.

Product: YAGER'S LINIMENT (Camphor and Turpentine Oil)

Variants: 4 FL OZ (118 mL) bottle, 8 FL OZ (236 mL) bottle, Camphor 3.1%, Turpentine Oil 8.12%

UPC Codes:

011169000046

011169000084

Lot Numbers:

0E267A

Distributed by The Oakhurst Co.

Product: ALCOLADO RELAMPAGO (Menthol and Camphor)

Variants: 7 FLUID OZ (207 ml) bottle, 16 FLUID OZ (472 ml) bottle, Menthol 1%, Camphor 1.5%

UPC Codes:

718864201029

718864201104

Lot Numbers:

0E280A (exp 10/23)

0E318A (exp 11/23)

1E109A (exp 3/24)

1E141A (exp 5/24)

0E280A (exp 11/23)

1E141A (exp 3/24)

Distributed by The Larkspur Group, Inc.

Product: Unguentine Ointment

Variants: 1 OZ (28 g) tube Improved Formula, 1 OZ (28.3g) tube Maximum Strength

UPC Codes:

011169102160

011169112503

Lot Numbers:

1E113A (exp 4/24)

Distributed by Oakhurst Company.

Product: Activator Concentrate

Variants: 1 FL. OZ. bottle, Sodium Fluoride 0.96%

Lot Numbers:

1E175B (exp 6/24)

Manufactured for All USA Direct, LLC.

Product: AstrinGyn (Ferric Subsulfate) Aqueous

Variants: 8 gm Single Use Vials, 259 mg/g

Model:

6065

Lot Numbers:

2E144A (exp 11/2023)

2E157A (exp 11/2023)

2E270A (exp 3/2024)

2E300A (exp 4/2024)

NDC:

59365-6065-0

Manufactured for CooperSurgical.

Product: Lugol's (Strong Iodine Solution USP)

Variants: 8mL Single Use Vials

Model:

6064

Lot Numbers:

2E235A (exp 2/2024)

2E293A (exp 3/2024)

NDC:

59365-6064-0

Manufactured for CooperSurgical.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92857

Status: Resolved

Manufacturer: Ecometics, Inc.

Sold By: Oakhurst Company; The Larkspur Group, Inc.; All USA Direct, LLC; CooperSurgical

Manufactured In: United States

Distributed To: Nationwide