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Recall Observatory FDA recall evidence

Drug product

tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA 920, (619) 894-6560.

D-0510-2019

November 12, 2015

Class II

Product summary

Firm
Mariposa Labs LLC
Event
Event 82112
Status
Terminated
Classification
Class II
Quantity
1654 jars
Official record key
drug-enforcement:D-0510-2019

Official wording

Reason: Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.

Code information: Lot#: 5589, Exp. 08/2017

Distribution pattern: Distributed in California

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