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Recall Observatory FDA recall evidence

Drug product

Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

D-1306-2014

December 27, 2013

Class II

Product summary

Firm
Mangiacotti
Event
Event 68136
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1306-2014

Official wording

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

Code information: Lot Code: 13350

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination