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Class II: temporary or reversible health riskTerminated

Island Kinetics dba Covalence CosMedix Serious Protection Recall

CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3

Island Kinetics dba Covalence · Chandler, AZ

Risk level
Class II
Reported by FDA
Sep 5, 2012
Recall ID
D-1670-2012
Check your lot numberHow we source this data

Summary

Island Kinetics dba Covalence recalled CosMedix Serious Protection starting Jul 13, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1670-2012 on Sep 5, 2012. Reason: Microbial Contamination of Non Sterile Product; mold. Status: Terminated.

Why it was recalled

Microbial Contamination of Non Sterile Product; mold

Product description

CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.

Lot numbers, UPCs & expiration codes

Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.

Where it was sold

Atlanta, Georgia

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-1670-2012
Classification
Class II
Status
Terminated
Recall initiated
Jul 13, 2012
FDA report date
Sep 5, 2012
Quantity
5311 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Island Kinetics dba Covalence

Original FDA data

Every field from FDA enforcement report D-1670-2012, exactly as published.

Show all FDA fields
City
Chandler
State
AZ
Status
Terminated
Country
United States
Event ID
62779
Address
460 S Benson Ln Ste 3
Code information
Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.
Postal code
85224-5663
Report date
Sep 5, 2012
Product type
Drugs
Recall number
D-1670-2012
Classification
Class II
Recalling firm
Island Kinetics dba Covalence
Product quantity
5311 bottles
Termination date
Sep 18, 2013
Reason for recall
Microbial Contamination of Non Sterile Product; mold
Voluntary / mandated
Voluntary: Firm initiated
Product description
CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.
Distribution pattern
Atlanta, Georgia
Recall initiation date
Jul 13, 2012
Initial firm notification
E-Mail
Center classification date
Aug 29, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1670-2012, published Sep 5, 2012. 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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