Recall Z-1089-2022— Total Resources Intl
Class II · Terminated
Class II FDA medical device recall by Total Resources Intl, initiated 2022-03-11, terminated 2025-01-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Total Resources Intl
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-11
- Terminated
- 2025-01-30
- Firm location
- City of Industry, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.