Finafta Baby Oral Gel Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Finafta Baby Oral Gel because it was manufactured under conditions that could impact product quality.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which corresponds to a moderate severity score of 2 under the rubric for minor labeling errors or low-risk contamination without reported illness.
Plain-English summary
Product Quest Manufacturing LLC is recalling Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube. The product is distributed by Efficient Laboratories, Inc., in Miami, FL. The recall covers all lots remaining within their expiry dates.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. This means the products were manufactured under conditions that could impact product quality. The distribution pattern is nationwide in the USA.
Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for further instructions.
The recalled product
- Product
- Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Topical Analgesic
- 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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Product Quest Manufacturing LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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