China Gel Inc: Drug Recall

Recall #D-0790-2021 · 03/10/2021

Class II: Risk

Recall Details

Recall Number: D-0790-2021
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: 3458 tubes

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

aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; 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.