Total Resources Intl recalls Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab La…

Recall date

March 11, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1090-2022

FDA classification

Class II

Brand / firm

Total Resources Intl

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Tablets under the Brand of Medique and Medi-Lyte, Product Code: M963.