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 76305-3
Check against the official notice below — it lists the full affected range.
China Gel Inc is recalling China-Gel White, a topical pain reliever containing camphor 3.00% and menthol 5.00%, in three package sizes: 2 oz tubes, 4 oz jars, and additional formats. The recall affects approximately 40,289 units distributed nationwide in the USA and internationally to Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, and the United Kingdom. The product is being recalled due to manufacturing deviations, as it was produced in a facility where contamination with B. cepacia was found in other products.
The affected products have multiple lot numbers and expiration dates ranging from April 2021 through October 2022, including lots B100JS, B183GQ, B255KZ, C030HS, C100AH, and C247JF. The recall source does not specify what action consumers should take with recalled product in their possession.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
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. 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 Quantity: 40,289 each Lot/code info: 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;
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.