Recalls / Class II
Class IID-0790-2021
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,
- Brand name
- Aulief
- Generic name
- Menthol And Camohor
- Active ingredients
- Camphor (natural), Menthol
- Route
- Topical
- NDC
- 76305-302
- FDA application
- M017
- Affected lot / code info
- Lot #: a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021
Why it was recalled
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Recalling firm
- Firm
- China Gel Inc
- Manufacturer
- China-Gel, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 501 W Golf Rd, N/A, Arlington Heights, Illinois 60005-3904
Distribution
- Quantity
- 3458 tubes
- 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
Timeline
- Recall initiated
- 2021-03-10
- FDA classified
- 2021-09-02
- Posted by FDA
- 2021-09-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0790-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.