Multi-event March 2021 FDA Recall China-gel by China Gel Inc
This Multi-event Class II drug recall was voluntarily initiated by China Gel Inc on March 10, 2021 for the product China-gel. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0790-2021
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
03-10-2021
09-08-2021
3458 tubes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
China Gel Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial 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
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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,
Batch or Lot Expiration Information
Lot# : a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021
Affected Packages Involved in this Recall
Recall Number: D-0788-2021
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
03-10-2021
09-08-2021
92,472 each
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
China Gel Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial 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
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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,
Batch or Lot Expiration 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
Affected Packages Involved in this Recall
Recall Number: D-0789-2021
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
03-10-2021
09-08-2021
40,289 each
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
China Gel Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial 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
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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,
Batch or Lot Expiration 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
