FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Keystone Laboratories Better Braids Un-Braid Recall

BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL

Keystone Laboratories Inc · Memphis, TN

Risk level
Class II
Reported by FDA
May 25, 2016
Recall ID
D-0853-2016
Check your lot numberHow we source this data

Summary

Keystone Laboratories recalled Better Braids Un-Braid starting Apr 4, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0853-2016 on May 25, 2016. Reason: Microbial Contamination of Non-Sterile Products: Failed S.aureus test. Status: Terminated.

Why it was recalled

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

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: 10AN5

Where it was sold

U.S. Including: MD and NJ

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0853-2016
Classification
Class II
Status
Terminated
Recall initiated
Apr 4, 2016
FDA report date
May 25, 2016
Quantity
7 Cases of 12 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Keystone Laboratories Inc

Original FDA data

Every field from FDA enforcement report D-0853-2016, exactly as published.

Show all FDA fields
City
Memphis
State
TN
Status
Terminated
Country
United States
Event ID
73895
Address
1103 Kansas St
Code information
Lot #: 10AN5
Postal code
38106-1913
Report date
May 25, 2016
Product type
Drugs
Recall number
D-0853-2016
Classification
Class II
Recalling firm
Keystone Laboratories Inc
Product quantity
7 Cases of 12 Bottles
Termination date
May 25, 2016
Reason for recall
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
U.S. Including: MD and NJ
Recall initiation date
Apr 4, 2016
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 16, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0853-2016, published May 25, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls