FDA Medical Device · Z-1089-2022

Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495, 20HBC01015CCREV3, 20HBC01084GLOWCC. Kit contents include ULTRAtab Laboratories Coated APAP 325 mg (Acetaminophen 325 mg), Product Code: L202L.

Class II · Terminated

ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system breach, which presents the possibility of cross-contamination where the potential contaminations are well known API's at well below efficacious dose levels.

Affected lots / codes — check yours against thisKit Item No./Lot/Expiration/Best if Used by Date: 10HBC01087/20097-03/6/30/2022; 10HBC01092A3PK/20086-10/6/30/2022; 10HBC01112/20100-10/6/30/2022; 10HBC01113/20062-04, 20063-04, 20064-04, 20083-04, 20084-03, 20085-03, 20104-03, 20105-03, 20106-03/6/30/2022; 10HBC01329GLRV1/20072-05, 20073-05, 20079-05, 20080-05, 20083-05, 20085-05, 20086-05/6/30/2022; 10OUT02086GLRV2/20086-04, 20087-04, 20090-04, 20091-04, 20092-04, 20093-04, 20094-04, 20097-04, 20098-04, 20099-04/6/30/2022; 16BLU01495/ 20079-10/6/30/2022; 20HBC01015CCREV3/20071-10/6/30/2022; 20HBC01084GLOWCC/20090-05, 20091-05, 20092-05, 20093-05/1/31/2022; 20HBC01084GLOWCC/20083-10, 20094-05, 20098-05/5/31/2022; 20HBC01084GLOWCC/20076-01, 20077-01, 20087-05/06/30/2022

Recalling firm: Total Resources Intl, City of Industry, CA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 188915
Distribution: US: IL, PA, VA, AR, TX, IA, DE, GA, NY, LA, AL, IN, MI, MO, NC, KS, CO, AZ, OH, MS, CA, FL, WI, KY, UT, OR, NH, TN, NV, CT
Recall initiated: March 11, 2022
Classified: May 13, 2022
Terminated: January 30, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1089-2022%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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