Class II · Moderate risk
Medicated Better Braids
Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.
Better Braids Un-Braid
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
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.
- Recalling firm
- Keystone Laboratories Inc
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0853-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Keystone Laboratories Inc
All 2016 recallsOther microbial contamination recalls from 2016
All microbial contamination recalls
Class II · Moderate risk
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Class II · Moderate risk
Lactulose Solution
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Class II · Moderate risk
Ondansetron HCI API
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Senna Syrup
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
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