Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1090-2022 — 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.

U.S. FDA — Device Enforcement · United States · 2022-03-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1090-2022
Date of alert: 2022-03-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Total Resources Intl
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1090-2022 — 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.

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