FDA-Drug2021-09-08Class II
CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, I
China Gel Inc
Hazard
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Sold states
Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
Affected count
40,289 each
Manufactured in
501 W Golf Rd, N/A, Arlington Heights, IL, United States
Products
CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0789-2021Don't want to check this manually?
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