FDAFDA · Food and drugs·Recall number 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 76305-302-01 ; 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,
Published September 8, 2021 · Recall initiated: March 10, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AULIEF
- Manufacturer
- China Gel Inc
- Distributor
- Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
- UPC
- 687806300031
- Lot
- Lot #: a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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