device · product 1 of 2
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.
- Recall number
- Z-1089-2022
- Initiated
- March 11, 2022
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Total Resources Intl
- Quantity
- 188915
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
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.
Code information
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
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