D-1319-2019 Class II Terminated
FDA drug recall D-1319-2019 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
Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 North 10th Street, Philadelphia, PA 19123.
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 # 6827
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1319-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026