FDA Recall D-0790-2021

China Gel Inc · Arlington Heights, IL

Class II Ongoing 1891 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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,

Lot / code: Lot #: a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021

Quantity: 3458 tubes

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.

Recall record

Recall number: D-0790-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
Recall initiated: 2021-03-10
Classified by FDA Center: 2021-09-02
FDA published: 2021-09-08
Recalling firm: China Gel Inc
Firm location: Arlington Heights, IL

Drug identification

Brand name(s): AULIEF
Generic name(s): MENTHOL AND CAMOHOR
Manufacturer(s): China-Gel, LLC
NDC(s): 76305-302
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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