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Class II: temporary or reversible health riskTerminated

Sigan Industries CVS Health Baby Eczema Moisturizing Recall

CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1

Sigan Industries Inc.

Risk level
Class II
Reported by FDA
Jul 19, 2017
Recall ID
D-0975-2017
Check your lot numberHow we source this data

Summary

Sigan Industries recalled CVS Health Baby Eczema Moisturizing starting Jun 13, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0975-2017 on Jul 19, 2017. Reason: Microbial Contamination of Non Sterile Products; out of specification Total Plate Count. Status: Terminated.

Why it was recalled

Microbial Contamination of Non Sterile Products; out of specification Total Plate Count

Product description

CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033

Lot numbers, UPCs & expiration codes

lot number 17-01319, exp 01/19

Where it was sold

CA

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-0975-2017
Classification
Class II
Status
Terminated
Recall initiated
Jun 13, 2017
FDA report date
Jul 19, 2017
Quantity
19,608 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Sigan Industries Inc.

Original FDA data

Every field from FDA enforcement report D-0975-2017, exactly as published.

Show all FDA fields
City
Brampton
Status
Terminated
Country
Canada
Event ID
77591
Address
296 Orenda Rd
Code information
lot number 17-01319, exp 01/19
Report date
Jul 19, 2017
Product type
Drugs
Recall number
D-0975-2017
Classification
Class II
Recalling firm
Sigan Industries Inc.
Product quantity
19,608 tubes
Termination date
Mar 15, 2019
Reason for recall
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Voluntary / mandated
Voluntary: Firm initiated
Product description
CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033
Distribution pattern
CA
Recall initiation date
Jun 13, 2017
Initial firm notification
E-Mail
Center classification date
Jul 13, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0975-2017, published Jul 19, 2017. 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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