China-gel White recall: CGMP Deviations
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,
Why was China-gel White recalled?
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- 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,
- Recalling firm
- China Gel Inc
- 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
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)