Drug & medication recalls Moderate risk

BETTER BRAIDS UN-BRAID recalled over sterility concerns

Recall date
April 4, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Keystone Laboratories Inc recalls BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. D…
Recall number
D-0853-2016
FDA classification
Class II
Brand / firm
Keystone Laboratories Inc
Sold / distributed
U.S. Including: MD and NJ

Why it was recalled

Microbial Contamination of Non-Sterile Products: Failed S.aureus test.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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