April 2016 FDA Recall Drug by Keystone Laboratories Inc
D-0853-2016 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Keystone Laboratories Inc on April 4, 2016 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in U.S. Including: MD and NJ and the recall is currently terminated.

Recall Number: D-0853-2016

Reason for Recall
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Initiated
04-04-2016
Reported
05-25-2016
Quantity
7 Cases of 12 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73895
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Keystone Laboratories Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: MD and NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-25-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : 10AN5