Why it was recalled
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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).
Lot numbers, UPCs & expiration codes
Batch #: 6736, 6826
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1311-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2019
- FDA report date
- Jun 5, 2019
- Quantity
- 17,850 pounds per batch
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Inopak Ltd
Original FDA data
Every field from FDA enforcement report D-1311-2019, exactly as published.
Show all FDA fields
- City
- Ringwood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82645
- Address
- 24 Executive Pkwy
- Code information
- Batch #: 6736, 6826
- Postal code
- 07456-1430
- Report date
- Jun 5, 2019
- Product type
- Drugs
- Recall number
- D-1311-2019
- Classification
- Class II
- Recalling firm
- Inopak Ltd
- Product quantity
- 17,850 pounds per batch
- Termination date
- Aug 28, 2024
- Reason for recall
- CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 22, 2019
- Initial firm notification
- Letter
- Center classification date
- May 29, 2019