D-0788-2021 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- September 8, 2021
- Initiation Date
- March 10, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92,472 each
Product Description
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; e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03; f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06; 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.
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
Code Information
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;