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Terminated

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.

FDA Recall Z-1090-2022 · Posted None

Recalling FirmTotal Resources Intl
Recall StatusTerminated
Product CodeLRR
Date Initiated2022-03-11
Date Terminated2025-01-30
Product Quantity891

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.

Firm Action

On 03/11/22 recall notices were sent to customers who were asked to do the following: 1) Examine your inventory and quarantine product subject to recall, which is the ULTRAtab products inside the kits, not the kits themselves . 2) The recall is extending to the retail level. If affected product has been further distributed, identify your customers, and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification. 3) Complete and return the Recall Acknowledgement to the recalling firm acknowledging receipt and understanding of the recall notice and documenting affected product (inside the kits) disposition. Affected products that are on hand are either marked as destroyed or returned. Customers with additional questions are encouraged to contact the recalling firm at (855) 883-3080 or email [email protected] Monday through Friday between 8:30 am to 3:30 pm (PST).

Root Cause

Process control

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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