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Recall Observatory FDA recall evidence

Drug product

UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403

D-035-2013

September 17, 2012

Class II

Product summary

Firm
DermaCare, Inc.
Event
Event 63378
Status
Terminated
Classification
Class II
Quantity
43,272 bottles
Official record key
drug-enforcement:D-035-2013

Official wording

Reason: Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.

Code information: Batch 2082-01085, 1852-01085, 2082-01213, 2152-01261, and 1782-01084

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination