D-1311-2019 Class II Terminated
FDA drug recall D-1311-2019 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
AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).
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 #: 6736, 6826
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1311-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026