CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tu...
FDA Drug Recall #D-0788-2021 — Class II — March 10, 2021
Recall Summary
| Recall Number | D-0788-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 10, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | China Gel Inc |
| Location | Arlington Heights, IL |
| Product Type | Drugs |
| 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
Lot / 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;
Other Recalls from China Gel Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0789-2021 | Class II | CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%),... | Mar 10, 2021 |
| D-0790-2021 | Class II | aulief (Organic Camphor 3.00% Organic Menthol 5... | Mar 10, 2021 |
Frequently Asked Questions
cGMP stands for Current Good Manufacturing Practice — the FDA's regulations governing drug manufacturing quality. A cGMP recall means the company failed to follow required manufacturing standards. This could involve inadequate testing, poor environmental controls, documentation failures, or process deviations. cGMP recalls do not always mean the product is directly harmful — in many cases, quality records are insufficient to confirm the product meets specifications. However, the FDA requires a recall because without proper documentation, product quality cannot be assured. These are often Class II or Class III recalls.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.