Recall Z-1089-2022 ยท LRR First Aid Kit With Drug
Total Resources Intl
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.
| Date | Mar 11, 2022 |
| Status | Terminated |
| 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. |
| 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 un |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.