Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab L
Summary
The FDA issued a Class II for Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT0208 by Total Resources Intl. Reason: ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrol.
Details
Source
Device Recall
External ID
Z-1090-2022
Action Date
2022-05-25
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: Kit Item No./Lot/Expiration/Best if Used by Date: 01REF2621/19268-10 01REF2621/20085-10/3/31/22, 01REF2621/20274-05/8/31/22, 10OUT02086REV3/21026-04/8/31/22,
Quantity Affected: 891
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-11
Company
City of Industry, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Total Resources Intl has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Total Resources Intl) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Total Resources Intl have FDA actions?
Total Resources Intl has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1090-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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