FDA Drug recall D-0790-2021
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…
- FDA Drug
- Class II
- ongoing
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of 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… by China Gel, citing CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0790-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-10 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | China Gel |
| Distribution | US |
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
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Identifiers
| upc | 687806300031 |
|---|---|
| upc | 687806300079 |
| upc | 687806300161 |
| ndc | 76305-302-03 |
| ndc | 76305-302-02 |
| ndc | 76305-302-01 |
| code_info | Lot #: a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0790-2021%22
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