China Gel Inc: Drug Recall

Recall #D-0789-2021 · 03/10/2021

Class II: Risk

Recall Details

Recall Number: D-0789-2021
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: 40,289 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 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,

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.