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.
What this means for you
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 mg),
- Manufacturer
- Total Resources Intl
- Category
- Drug
- Hazard
- cross-contamination
- manufacturing-defect
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:
- AL
- AR
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- IA
- IL
- IN
- KS
- KY
- LA
- MI
- MO
- MS
- NC
- NH
- NV
- NY
- OH
- OR
- PA
- TN
- TX
- UT
- VA
- WI
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