Recalls / Class II
Class IID-1311-2019
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).
- Affected lot / code info
- Batch #: 6736, 6826
Why it was recalled
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Recalling firm
- Firm
- Inopak Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 24 Executive Pkwy, N/A, Ringwood, New Jersey 07456-1430
Distribution
- Quantity
- 17,850 pounds per batch
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-04-22
- FDA classified
- 2019-05-29
- Posted by FDA
- 2019-06-05
- Terminated
- 2024-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1311-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.