The Recall Desk
ModerateFDA (Drugs)·D-1096-2023·Announced 2023-08-30

Blis-To-Sol Tolnaftate Liquid Recalled for Manufacturing Practice Deviations

Ecometics, Inc. is recalling Blis-To-Sol Liquid (Tolnaftate) nationwide due to manufacturing practice violations. No illnesses have been reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries and no documented product defect. The hazard is a manufacturing practice deviation without specification of the underlying violation.

Plain-English summary

Ecometics, Inc. is recalling Blis-To-Sol Liquid (Tolnaftate), 1%, in two package sizes. The affected products are 1 fluid ounce (29.5 mL) bottles (UPC 0 11169 20011 8) and 1.85 fluid ounce (54.5 mL) bottles (UPC 0 11169 20012 5), lot 9E098A. Approximately 9,816 bottles of the 1 oz size and 10,776 bottles of the 1.85 oz size were distributed nationwide.

The FDA Class II recall was initiated because the product was not manufactured under current good manufacturing practices (CGMP).

Consumers who have purchased this product should stop using it and contact Ecometics, Inc. for return instructions. Patients needing treatment for fungal infections should consult their healthcare provider about alternative medications.

The recalled product

Product
Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
Manufacturer
Ecometics, Inc.
Category
Drug
Hazard
  • cgmp-violation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 9E098A

Distribution

Distributed nationwide across the United States.

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