The Recall Desk
SevereFDA (Drugs)·D-0853-2016·Announced 2016-05-25

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.

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

Distributed in 2 states: