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Class III: unlikely to cause harmTerminated

Oxygen Development Life Brand Clear Action Acne Treatment Recall

Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1

Oxygen Development Llc · Palm Springs, FL

Risk level
Class III
Reported by FDA
Mar 14, 2018
Recall ID
D-0584-2018
Check your lot numberHow we source this data

Summary

Oxygen Development recalled Life Brand Clear Action Acne Treatment starting Jan 24, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0584-2018 on Mar 14, 2018. Reason: Superpotent drug: failed assay throughout the stick after 6 months stability. Status: Terminated.

Why it was recalled

Superpotent drug: failed assay throughout the stick after 6 months stability.

Product description

Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653

Lot numbers, UPCs & expiration codes

Lot #: 060E

Where it was sold

Canada

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-0584-2018
Classification
Class III
Status
Terminated
Recall initiated
Jan 24, 2018
FDA report date
Mar 14, 2018
Quantity
12216 sticks
Recall type
Voluntary: Firm initiated
Recalling firm
Oxygen Development Llc

Original FDA data

Every field from FDA enforcement report D-0584-2018, exactly as published.

Show all FDA fields
City
Palm Springs
State
FL
Status
Terminated
Country
United States
Event ID
79338
Address
1525 S Congress Ave
Code information
Lot #: 060E
Postal code
33406-5916
Report date
Mar 14, 2018
Product type
Drugs
Recall number
D-0584-2018
Classification
Class III
Recalling firm
Oxygen Development Llc
Product quantity
12216 sticks
Termination date
Apr 3, 2019
Reason for recall
Superpotent drug: failed assay throughout the stick after 6 months stability.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653
Distribution pattern
Canada
Recall initiation date
Jan 24, 2018
Initial firm notification
Telephone
Center classification date
Mar 9, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0584-2018, published Mar 14, 2018. 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.

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