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Recall Observatory FDA recall evidence

Drug product

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

D-0975-2017

June 13, 2017

Class II

Product summary

Firm
Sigan Industries Inc.
Event
Event 77591
Status
Terminated
Classification
Class II
Quantity
19,608 tubes
Official record key
drug-enforcement:D-0975-2017

Official wording

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

Code information: lot number 17-01319, exp 01/19

Distribution pattern: CA

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification