Why it was recalled
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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.
Lot numbers, UPCs & expiration codes
Batch # 6827
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-1319-2019
- 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-1319-2019, 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 # 6827
- Postal code
- 07456-1430
- Report date
- Jun 5, 2019
- Product type
- Drugs
- Recall number
- D-1319-2019
- 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
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 22, 2019
- Initial firm notification
- Letter
- Center classification date
- May 29, 2019