China Gel Inc: Drug Recall

Recall #D-0788-2021 · 03/10/2021

Class II: Risk

Recall Details

Recall Number: D-0788-2021
Classification: Class II
Product Type: Drug
Recalling Firm: China Gel Inc
Status: Ongoing
Date Initiated: 03/10/2021
Location: Arlington Heights, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 92,472 each

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.

Product Description

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,

Distribution Pattern

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

Other Recalls by China Gel Inc

Class II: Risk 03/10/2021

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II: Risk 03/10/2021

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

View all recalls by China Gel Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.