D-0221-2019 Class II Terminated
FDA drug recall D-0221-2019 was initiated by S.C. Johnson Professional on October 26, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Product was released to market prior to microbiological testing. The recall status is terminated (terminated September 8, 2020). Affected quantity: 258 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- November 14, 2018
- Initiation Date
- October 26, 2018
- Termination Date
- September 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 258 cases
Product Description
Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
Reason for Recall
CGMP Deviations: Product was released to market prior to microbiological testing.
Distribution Pattern
NC
Code Information
Lot 9085