Drug product
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9
D-1149-2022
Product summary
- Event
- Event 89947
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,020 bottles
- Official record key
drug-enforcement:D-1149-2022
Official wording
Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Code information: Batch# 100620-128201, 100620-128202, 100620-128203, 100620-128204, 100620-128205, 100620-128206, 100620-128207, 100620-128208, 100620-128209, 100620-128210, 100620-128211, 100620-128212
Distribution pattern: Firm failed to provide distribution pattern information.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations