Z-1089-2022Class II

Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112...

Name: Z-1089-2022 Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112...
Creator: Total Resources Intl
Published: 2022-03-11
License: https://open.fda.gov/license/

Total Resources Intl / initiated 2022-03-11 / Terminated / root cause: manufacturing process

FDA source

Total Resources Intl began a recall of Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495... on 2022-03-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1089-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-11
Posted: 2022-05-13
Terminated: 2025-01-30
Recalling firm: Total Resources Intl
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.
Product code: LRR First Aid Kit With Drug
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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).
Quantity in commerce: 188915
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
Product codes and lots: Kit Item No./Lot/Expiration/Best if Used by Date: 10HBC01087/20097-03/6/30/2022; 10HBC01092A3PK/20086-10/6/30/2022; 10HBC01112/20100-10/6/30/2022; 10HBC01113/20062-04, 20063-04, 20064-04, 20083-04, 20084-03, 20085-03, 20104-03, 20105-03, 20106-03/6/30/2022; 10HBC01329GLRV1/20072-05, 20073-05, 20079-05, 20080-05, 20083-05, 20085-05, 20086-05/6/30/2022; 10OUT02086GLRV2/20086-04, 20087-04, 20090-04, 20091-04, 20092-04, 20093-04, 20094-04, 20097-04, 20098-04, 20099-04/6/30/2022; 16BLU01495/ 20079-10/6/30/2022; 20HBC01015CCREV3/20071-10/6/30/2022; 20HBC01084GLOWCC/20090-05, 20091-05, 20092-05, 20093-05/1/31/2022; 20HBC01084GLOWCC/20083-10, 20094-05, 20098-05/5/31/2022; 20HBC01084GLOWCC/20076-01, 20077-01, 20087-05/06/30/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1089-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1089-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-13
Z-1090-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-13

Product code LRR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)