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Recall Observatory FDA recall evidence

Drug product

Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube, UPC code: 634084490091 (US) UPC Code: 634084490114 (Canada)

D-324-2014

September 24, 2013

Class II

Product summary

Firm
W.S. Badger Company Inc.
Event
Event 66342
Status
Terminated
Classification
Class II
Quantity
36,272 Tubes
Official record key
drug-enforcement:D-324-2014

Official wording

Reason: Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.

Code information: Lot number 3024A EXP 01/15; 3057A EXP 02/15; 3063A EXP 03/15; 3063B EXP 03/15; 3132A; 3133A EXP 05/15.

Distribution pattern: Nationwide and Canada, Greece, Singapore, Thailand, Norway, American Samoa.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination