FDA Drug Recalls

Recalls / Class II

Class IID-1319-2019

Product

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.

Affected lot / code info
Batch # 6827

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-1319-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.