Recall Enforment Report D-0791-2021
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Charles Paint Research Inc, originally initiated on 09-02-2020 for the 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 The product was recalled due to cgmp deviations: product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.. The product was distributed in Distributed In Michigan and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0791-2021 | 09-02-2020 | 09-15-2021 | Class II | 3,900 gallons | 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 | CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits. | Terminated |
| D-0792-2021 | 09-02-2020 | 09-15-2021 | Class II | 600 gallons | 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 | CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits. | Terminated |
