aulief — Class II drug recall D-0790-2021
Ongoing recall by China Gel Inc, reported 2021-09-08, distributed nationwide. CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepaci
| Recall number | D-0790-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | China Gel Inc, Arlington Heights, IL, United States |
| Recall initiated | 2021-03-10 |
| Classified | 2021-09-02 |
| Reported by FDA | 2021-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, FR, GB, IE, NO, RU, SG |
| Quantity | 3,458 tubes |
| Reason classes | cgmp |
| Pathogens | burkholderia |
| UPC / GTIN / UDI-DI | 00687806300031, 00687806300079, 00687806300161 |
| NDC | 76305-0302, 76305-0302-01, 76305-0302-02, 76305-0302-03 |
| Expiration dates | 2021-05 |
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,
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0790-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.