D-0361-2021 Class II Terminated
FDA drug recall D-0361-2021 was initiated by Spartan Chemical Co Inc on Mar 29, 2021 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Oct 16, 2023). Affected quantity: 400 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 21, 2021
- Initiation Date
- Mar 29, 2021
- Termination Date
- Oct 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 containers
Product Description
Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85
Reason for Recall
CGMP Deviations
Distribution Pattern
Nationwide USA and Puerto Rico; Mexico
Code Information
Lot, expiry: Lot 538885, exp 1/25/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0361-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026