Drug 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,
D-0790-2021
Product summary
- Firm
- China Gel Inc
- Event
- Event 87496
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3458 tubes
- Official record key
drug-enforcement:D-0790-2021
Official wording
Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Code information: Lot #: a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021
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
Derived failure modes
-
Manufacturing or process control
CGMP deviations