CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8...
FDA Recall #D-0789-2021 — Class II — March 10, 2021
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,
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.
Recalling Firm
China Gel Inc — Arlington Heights, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
40,289 each
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
Code Information
Lot #: a)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; b)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; c)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; d)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; e)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; f)B100JS, Exp 04/2021; B183GQ, EXP 09-2021; B255KZ, EXP 09-2021; C030HS, EXP 04-2022; C100AH, EXP 06-2022; C247JF, EXP 10-2022;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.