Drug product
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).
D-1311-2019
Product summary
- Firm
- Inopak Ltd
- Event
- Event 82645
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,850 pounds per batch
- Official record key
drug-enforcement:D-1311-2019
Official wording
Reason: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Code information: Batch #: 6736, 6826
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations