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.
Product description
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 numbers, UPCs & expiration codes
Lot #: a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021
Where it was sold
Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0790-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 10, 2021
- FDA report date
- Sep 8, 2021
- Quantity
- 3458 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- China Gel Inc
Original FDA data
Every field from FDA enforcement report D-0790-2021, exactly as published.
Show all FDA fields
- City
- Arlington Heights
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 87496
- Address
- 501 W Golf Rd
- Code information
- Lot #: a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021
- Postal code
- 60005-3904
- Report date
- Sep 8, 2021
- Product type
- Drugs
- Recall number
- D-0790-2021
- Classification
- Class II
- Recalling firm
- China Gel Inc
- Product 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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,
- 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
- Recall initiation date
- Mar 10, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 2, 2021