Cetylite Recalls Cetacaine Topical Anesthetic Due to Low Tetracaine Levels
Cetylite Industries is recalling Cetacaine Topical Anesthetic Liquid because the tetracaine ingredient is below specification limits at the 21-month stability test point.
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: The recall is classified as FDA Class II, and the hazard is a subpotent drug (lack of efficacy) rather than a direct physical or toxicological injury risk, fitting the Moderate criteria for low-risk contamination or labeling/quality issues without reported harm.
Plain-English summary
Cetylite Industries, Inc. is recalling Cetacaine Topical Anesthetic Liquid, a prescription-only product containing benzocaine, butamben, and tetracaine hydrochloride. The recall affects 14 g bottles, 14 g kits, and 30 g bottles distributed nationwide.
The recall was initiated because one of the active ingredients, tetracaine, was found to be below the specification limit at the 21-month stability test point. This indicates the product may be subpotent, meaning it may not provide the intended therapeutic effect.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. The affected lots are 470 (exp. 04/13), 471 (exp. 06/13), and 472 (exp. 10/13).
The recalled product
- Product
- CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE)
- Brand
- CETACAINE ANESTHETIC
- Manufacturer
- Cetylite Industries, Inc.
- Category
- Drug — Topical Anesthetic
- Hazard
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 (3)
- Lot 470 exp. 04/13
- 471 exp. 06/13
- 472 exp. 10/13
Distribution
Distributed nationwide across the United States.
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