Why it was recalled
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Product description
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.
Lot numbers, UPCs & expiration codes
Batch #: 1180103, Exp 2021.01.02; 180104, Exp 2021.01.03; 80105, Exp 2021.01.04; 180106, Exp 2021.01.05; 80107, Exp 2021.01.06.
Where it was sold
Nationwide in the USA
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-1277-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 19, 2020
- FDA report date
- Jun 3, 2020
- Quantity
- 4,960 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wuhan Bingbing Pharmaceutical Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-1277-2020, exactly as published.
Show all FDA fields
- City
- Wuhan
- Status
- Ongoing
- Country
- China
- Event ID
- 85726
- Address
- Building
- Address (line 2)
- F, No.5, Kangda Street
- Code information
- Batch #: 1180103, Exp 2021.01.02; 180104, Exp 2021.01.03; 80105, Exp 2021.01.04; 180106, Exp 2021.01.05; 80107, Exp 2021.01.06.
- Report date
- Jun 3, 2020
- Product type
- Drugs
- Recall number
- D-1277-2020
- Classification
- Class II
- Recalling firm
- Wuhan Bingbing Pharmaceutical Co., Ltd.
- Product quantity
- 4,960 boxes
- Reason for recall
- CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 19, 2020
- Initial firm notification
- Center classification date
- May 28, 2020