FDA recall D-0788-2021

China Gel Inc · Class II · drug

Product

CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03; d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04; e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03; f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,

Reason for recall

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

Distribution

Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom

Key facts

Status
Ongoing
Initiation date
2021-03-10
Report date
2021-09-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arlington Heights, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0788-2021