D-1315-2019 Class II Terminated
FDA drug recall D-1315-2019 was initiated by Inopak Ltd on Apr 22, 2019 and is designated Class II. Reason for recall: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. The recall status is terminated (terminated Aug 28, 2024). Affected quantity: 17,850 pounds per batch.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 5, 2019
- Initiation Date
- Apr 22, 2019
- Termination Date
- Aug 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,850 pounds per batch
Product Description
Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566
Reason for Recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Distribution Pattern
Nationwide in the USA
Code Information
Batch #: 6802, 6803, 6909, 6655
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1315-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026