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;
Check against the official notice below — it lists the full affected range.
China Gel Inc is recalling China Gel, a topical pain reliever containing camphor 3.00% and menthol 5.00%, due to current Good Manufacturing Practice (CGMP) deviations. The product was manufactured in a facility where contamination with B. cepacia was found in other products. The recall affects 92,472 units distributed nationwide in the USA as well as internationally in Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, and the United Kingdom.
The affected products include 2 ounce tubes (NDC 76305-300-13), 4 ounce jars (NDC 76305-300-02), and 6 ounce sizes in multiple lot codes with expiration dates ranging from May 2021 through December 2022. The recall record does not specify what action affected consumers should take.
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: 92,472 each Lot/code info: Lot #: a)B122DY, exp 2021-05; B183GN, exp 2021-07; B262BF, exp 2021-09; C002KF, exp 2022-01; C030HT, exp 2022-02; C094LT, exp 2022-04; C275CW, exp 2022-10; C338CH, exp 2022-12; b) B122DX, exp 2021-05; B183GP, exp 2021-07; B262BE, exp 2021-09; C002KF, exp 2022-01; C030HT, exp 2022-02; C094LT, exp 2022-04; C275CW, exp 2022-10; C330BG, exp 2022-12 c) B122DY, exp 2021-05; B183GN, exp 2021-07; B262BF, exp 2021-09; C002KF, exp 2022-01; C030HT, exp 2022-02; C094LT, exp 2022-04;C156FF, exp 2022-06; C247JB, exp 2022-09; C338CH, exp 2022-12. d)B122DX, Exp 05/2021; B122DY , EXP 05-2021; B183GP, EXP 07-2021; B262BE, EXP 09-2021; B262BF, EXP 09-2021; C002KF, EXP 01-2022; C030HT, EXP 02-2022; C094LT, EXP 04-2022; C156FF, EXP 06-2022; C247JB, EXP 09-2022; C275CW, EXP 10-2022; C330BG, EXP 12-2022; 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) B122DY , EXP 05-2021; B183GN, EXP 07-2021; B183GP, EXP 07-2021; B262BF, EXP 01-2022; C002KF, EXP 02-2022; C030HT, EXP 02-2022; C094LT, EXP 04-2022; C156FF, EXP 09-2022; C275CW, EXP 12-2022; C338CH, EXP 05-2022;
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.