FDA recall Z-1089-2022

Total Resources Intl · Class II · device

Product

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.

Reason for recall

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.

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

Key facts

Status
Terminated
Initiation date
2022-03-11
Report date
2022-05-25
Termination date
2025-01-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
City of Industry, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1089-2022