FDA recall D-1319-2019

Inopak Ltd · Class II · drug

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.

Reason for recall

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2019-04-22
Report date
2019-06-05
Termination date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ringwood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1319-2019