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Class III: unlikely to cause harmTerminated

Sigan Industries Eczema Skin Relief Lotion Recall

Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion

Sigan Industries Inc.

Risk level
Class III
Reported by FDA
Jan 22, 2020
Recall ID
D-0782-2020
Check your lot numberHow we source this data

Summary

Sigan Industries recalled Eczema Skin Relief Lotion starting Jan 7, 2020. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0782-2020 on Jan 22, 2020. Reason: Microbial contamination of non-sterile product. Status: Terminated.

Why it was recalled

Microbial contamination of non-sterile product.

Product description

Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.

Lot numbers, UPCs & expiration codes

Lot#: 2508-08-337, 2538-08-337, Exp 8/2020

Where it was sold

IL

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-0782-2020
Classification
Class III
Status
Terminated
Recall initiated
Jan 7, 2020
FDA report date
Jan 22, 2020
Quantity
11,004 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Sigan Industries Inc.

Original FDA data

Every field from FDA enforcement report D-0782-2020, exactly as published.

Show all FDA fields
City
Brampton
Status
Terminated
Country
Canada
Event ID
84678
Address
296 Orenda Rd
Code information
Lot#: 2508-08-337, 2538-08-337, Exp 8/2020
Report date
Jan 22, 2020
Product type
Drugs
Recall number
D-0782-2020
Classification
Class III
Recalling firm
Sigan Industries Inc.
Product quantity
11,004 bottles
Termination date
Aug 12, 2022
Reason for recall
Microbial contamination of non-sterile product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Distribution pattern
IL
Recall initiation date
Jan 7, 2020
Initial firm notification
Letter
Center classification date
Jan 16, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0782-2020, published Jan 22, 2020. 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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