Drug product
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
D-0791-2021
Product summary
- Event
- Event 88552
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,900 gallons
- Official record key
drug-enforcement:D-0791-2021
Official wording
Reason: CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Code information: Lot# 20-151 to 20-159 and 20-161 to20-163, Exp 06/11/2022
Distribution pattern: Distributed in Michigan
Derived failure modes
-
Manufacturing or process control
CGMP Deviations