Drug product
TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved, 76590-8347-1, 3780 mL, 3.78 Liters (1 Gallon). Torco Race Fuels 2527 W. Dallas Ave. Apache Junction, AZ, 85120
D-0786-2022
Product summary
- Firm
- Torco Race Fuels
- Event
- Event 90067
- Status
- Terminated
- Classification
- Class II
- Quantity
- 127 gallons
- Official record key
drug-enforcement:D-0786-2022
Official wording
Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Code information: No lot or Expiration date on Product
Distribution pattern: Distributed in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations