Why it was recalled
CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Product description
Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
Lot numbers, UPCs & expiration codes
Lot #:14122921, Exp.12/30/20119, 15091512, Exp. 9/15/2020, 6032321, Exp. 3/23/2021, 17030921, Exp. 3/09/2022
Where it was sold
Nationwide within US
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-0624-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 29, 2018
- FDA report date
- Apr 18, 2018
- Quantity
- 15,190 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- United Pacific Co Ltd
Original FDA data
Every field from FDA enforcement report D-0624-2018, exactly as published.
Show all FDA fields
- City
- South El Monte
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79693
- Address
- 11030 Weaver Ave
- Code information
- Lot #:14122921, Exp.12/30/20119, 15091512, Exp. 9/15/2020, 6032321, Exp. 3/23/2021, 17030921, Exp. 3/09/2022
- Postal code
- 91733-3540
- Report date
- Apr 18, 2018
- Product type
- Drugs
- Recall number
- D-0624-2018
- Classification
- Class II
- Recalling firm
- United Pacific Co Ltd
- Product quantity
- 15,190 boxes
- Termination date
- Jan 24, 2019
- Reason for recall
- CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
- Distribution pattern
- Nationwide within US
- Recall initiation date
- Mar 29, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 10, 2018