Durex Condoms Recalled for Missing Benzocaine Labeling Information
Reckitt Benckiser LLC is recalling Durex Pleasure Pack condoms because the package labeling is missing information about the active ingredient Benzocaine.
The agency’s classification
FDA (Devices): 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 and involves a labeling error regarding an active ingredient, which aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Reckitt Benckiser LLC is recalling Durex Pleasure Pack condoms due to missing information on the package labeling associated with the active ingredient Benzocaine. The recall involves 3-count, 12-count, and 24-count packages of ultra-fine lubricated latex condoms.
The affected products were distributed nationwide and to foreign markets. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers should check their Durex Pleasure Pack condoms for the specific item codes and lot codes listed in the official recall notice. If the product matches the recalled items, consumers should stop using them and follow the instructions provided by the recalling firm.
The recalled product
- Product
- Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04…
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Medical Device — Condoms
- Hazard
- Affected units
- 108,342
Distribution
Distributed nationwide across the United States.
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