FDA Recall D-1503-2020

Spartan Chemical Co Inc · Maumee, OH

Class I — life-threatening Terminated 1202 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.

Lot / code: a) 42.27 oz cartridge: 518491, 518492, 518498, 518499, 518500, 520057, 520058, 520060, 520061; b) 1 gallon container: 520032, Exp. 06/30/2022.

Quantity: a) 60,796 cartridges, b) 420 gallon containers

Reason for recall

Microbial contamination of non-sterile products: positive microbial contamination in product.

Recall record

Recall number: D-1503-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide USA, Panama, St. Maarten
Recall initiated: 2020-07-01
Classified by FDA Center: 2020-08-14
FDA published: 2020-08-12
Terminated: 2023-10-16
Recalling firm: Spartan Chemical Co Inc
Firm location: Maumee, OH

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