The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1089-2022·Announced 2022-05-25

Acetaminophen tablets in first aid kits recalled for contamination risk

Total Resources International first aid kits containing acetaminophen tablets are being recalled due to potential cross-contamination from manufacturing equipment damage at the tablet supplier.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with theoretical hazard (potential cross-contamination at sub-therapeutic levels). Per the rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).

Plain-English summary

Total Resources International is recalling multiple models of first aid kits containing acetaminophen tablets due to potential contamination during manufacturing. The recall affects 188,915 units distributed across the United States.

The acetaminophen tablets were manufactured by ULTRAtab Laboratories and potentially exposed to cross-contamination from a breach in the fluid bed drier exhaust system at the manufacturing facility. Any contamination would consist of other active pharmaceutical ingredients at levels below therapeutic doses.

The affected kits have been distributed to consumers across the United States with various lot numbers and expiration dates ranging from January 31, 2022 to June 30, 2022. Specific item numbers and lot numbers are available on the FDA recall notice.

Consumers who have purchased these first aid kits should stop using the acetaminophen tablets and contact Total Resources International for a refund or replacement. Consult the FDA recall notice for specific lot numbers and product item codes.

The recalled product

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…
Manufacturer
Total Resources Intl
Category
Drug
Hazard
Affected units
188,915

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 30 states:

Part of a larger recall action

This product is one of 2 recalled by Total Resources Intl under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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