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Recall Observatory FDA recall evidence

Drug product

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.

D-0782-2020

January 07, 2020

Class III

Product summary

Firm
Sigan Industries Inc.
Event
Event 84678
Status
Terminated
Classification
Class III
Quantity
11,004 bottles
Official record key
drug-enforcement:D-0782-2020

Official wording

Reason: Microbial contamination of non-sterile product.

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

Distribution pattern: IL

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination