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Recall Observatory FDA recall evidence

Device product

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.

Z-1090-2022

March 11, 2022

Class II

Product summary

Firm
Total Resources Intl
Event
Event 89899
Status
Terminated
Classification
Class II
Quantity
891
Official record key
device-enforcement:Z-1090-2022

Official wording

Reason: 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.

Code information: Kit Item No./Lot/Expiration/Best if Used by Date: 01REF2621/19268-10 01REF2621/20085-10/3/31/22, 01REF2621/20274-05/8/31/22, 10OUT02086REV3/21026-04/8/31/22,

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.