Keystone Recalls Better Braid Un-Braid Due to Microbial Contamination
Keystone Laboratories is recalling Better Braid Un-Braid salicylic acid product due to a failed S. aureus test. The product was distributed in Maryland and New Jersey.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk pathogen (S. aureus) in a non-sterile product, meeting the criteria for a Severe rating.
Plain-English summary
Keystone Laboratories Inc is recalling Better Braid Un-Braid (salicylic acid), Le Demelant, packaged in 12 FL. OZ. (355 ml) bottles. The recall is due to microbial contamination, specifically a failed S. aureus test. The product is an over-the-counter item distributed by Keystone Laboratories.
The affected product is identified by Lot # 10AN5 and UPC 07059600430. The recall involves 7 cases of 12 bottles. Distribution was limited to the United States, specifically Maryland and New Jersey.
Consumers who have this product should stop using it and contact Keystone Laboratories for further instructions. The FDA has classified this recall as Class II, indicating a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
- Manufacturer
- Keystone Laboratories Inc
- Category
- Drug — Topical OTC
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 #: 10AN5
Distribution
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